Angiotensin-Converting Enzyme Inhibitors or Angiotensin-Receptor Blockers for Advanced Chronic Kidney Disease : A Systematic Review and Retrospective Individual Participant-Level Meta-analysis of Clinical Trials.

BACKGROUND: In patients with advanced chronic kidney disease (CKD), the effects of initiating treatment with an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin-receptor blocker (ARB) on the risk for kidney failure with replacement therapy (KFRT) and death remain unclear. PURPOSE: To examine the association of ACEi or ARB treatment initiation, relative to a non-ACEi or ARB comparator, with rates of KFRT and death. DATA SOURCES: Ovid Medline and the Chronic Kidney Disease Epidemiology Collaboration Clinical Trials Consortium from 1946 through 31 December 2023. STUDY SELECTION: Completed randomized controlled trials testing either an ACEi or an ARB versus a comparator (placebo or antihypertensive drugs other than ACEi or ARB) that included patients with a baseline estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2. DATA EXTRACTION: The primary outcome was KFRT, and the secondary outcome was death before KFRT. Analyses were done using Cox proportional hazards models according to the intention-to-treat principle. Prespecified subgroup analyses were done according to baseline age (<65 vs. ≥65 years), eGFR (<20 vs. ≥20 mL/min/1.73 m2), albuminuria (urine albumin-creatinine ratio <300 vs. ≥300 mg/g), and history of diabetes. DATA SYNTHESIS: A total of 1739 participants from 18 trials were included, with a mean age of 54.9 years and mean eGFR of 22.2 mL/min/1.73 m2, of whom 624 (35.9%) developed KFRT and 133 (7.6%) died during a median follow-up of 34 months (IQR, 19 to 40 months). Overall, ACEi or ARB treatment initiation led to lower risk for KFRT (adjusted hazard ratio, 0.66 [95% CI, 0.55 to 0.79]) but not death (hazard ratio, 0.86 [CI, 0.58 to 1.28]). There was no statistically significant interaction between ACEi or ARB treatment and age, eGFR, albuminuria, or diabetes (P for interaction > 0.05 for all). LIMITATION: Individual participant-level data for hyperkalemia or acute kidney injury were not available. CONCLUSION: Initiation of ACEi or ARB therapy protects against KFRT, but not death, in people with advanced CKD. PRIMARY FUNDING SOURCE: National Institutes of Health. (PROSPERO: CRD42022307589).

Association between Acute Declines in Estimated Glomerular Filtration Rate during Renin-Angiotensin System Inhibition and Risk of Adverse Outcomes.

BACKGROUND: Declines in glomerular filtration rate (GFR) occur commonly when renin-angiotensin system (RAS) inhibitors are started. Our objective was to determine the relation between declines in estimated GFR during trials of RAS inhibition and kidney outcomes. METHODS: We included participants with CKD (estimated GFR<60 mL/min/1.73m2) from 16 trials of RAS inhibition. The exposure was subacute declines in estimated GFR expressed as % change between randomization and month 3, and in the subset of trials with data available, we also examined % change in eGFR between randomization and month 1. The primary outcome was kidney failure with replacement therapy. Cox proportional hazards models were used to examine the association between subacute declines in eGFR and risk of kidney failure. We used spline models to identify the threshold of change in eGFR below which RAS inhibition was favorable (conservatively comparing a given decline in eGFR with RAS inhibition to no decline in the comparator). RESULTS: 11,800 individuals with mean eGFR 43 (SD 11) mL/min/1.73m2 and median urine albumin/creatinine ratio of 362 mg/g (IQR 50, 1367) were included, and 1,162 (10%) developed kidney failure. The threshold of decline in eGFR that favored use of RAS inhibitors for kidney failure was estimated to be up to 13% (95%CI 8%, 17%) over a 3-month interval and up to 21% (95%CI 15%, 27%) over a 1-month interval after starting RAS inhibitors. CONCLUSIONS: In people treated with RAS inhibitors, ≤ 13% decline in eGFR over a 3-month period or ≤21% decline over a 1-month period was associated with lower risk of kidney failure compared with no decline with the use of placebo or other agents.

A meta-analysis of randomized controlled clinical trials for implications of acute treatment effects on glomerular filtration rate for long-term kidney protection.

Pharmacologic interventions to slow chronic kidney disease progression, such as ACE-inhibitors, angiotensin receptor blockers, or sodium glucose co-transporter 2 inhibitors, often produce acute treatment effects on glomerular filtration rate (GFR) that differ from their long-term chronic treatment effects. Observational studies assessing the implications of acute effects cannot distinguish acute effects from GFR changes unrelated to the treatment. Here, we performed meta-regression analysis of multiple trials to isolate acute effects to determine their long-term implications. In 64 randomized controlled trials (RCTs), enrolling 154,045 participants, we estimated acute effects as the mean between-group difference in GFR slope from baseline to three months, effects on chronic GFR slope (starting at three months after randomization), and effects on three composite kidney endpoints defined by kidney failure (GFR 15 ml/min/1.73m2 or less, chronic dialysis, or kidney transplantation) or sustained GFR declines of 30%, 40% or 57% decline, respectively. We used Bayesian meta-regression to relate acute effects with treatment effects on chronic slope and the composite kidney endpoints. Overall, acute effects were not associated with treatment effects on chronic slope. Acute effects were associated with the treatment effects on composite kidney outcomes such that larger negative acute effects were associated with lesser beneficial effects on the composite kidney endpoints. Associations were stronger when the kidney composite endpoints were defined by smaller thresholds of GFR decline (30% or 40%). Results were similar in a subgroup of interventions with supposedly hemodynamic effects that acutely reduce GFR. For studies with GFR 60 mL/min/1.73m2 or under, negative acute effects were associated with larger beneficial effects on chronic GFR slope. Thus, our data from a large and diverse set of RCTs suggests that acute effects of interventions may influence the treatment effect on clinical kidney outcomes.

Change in Albuminuria and GFR Slope as Joint Surrogate End Points for Kidney Failure: Implications for Phase 2 Clinical Trials in CKD.

SIGNIFICANCE STATEMENT: Changes in albuminuria and GFR slope are individually used as surrogate end points in clinical trials of CKD progression, and studies have demonstrated that each is associated with treatment effects on clinical end points. In this study, the authors sought to develop a conceptual framework that combines both surrogate end points to better predict treatment effects on clinical end points in Phase 2 trials. The results demonstrate that information from the combined treatment effects on albuminuria and GFR slope improves the prediction of treatment effects on the clinical end point for Phase 2 trials with sample sizes between 100 and 200 patients and duration of follow-up ranging from 1 to 2 years. These findings may help inform design of clinical trials for interventions aimed at slowing CKD progression. BACKGROUND: Changes in log urinary albumin-to-creatinine ratio (UACR) and GFR slope are individually used as surrogate end points in clinical trials of CKD progression. Whether combining these surrogate end points might strengthen inferences about clinical benefit is unknown. METHODS: Using Bayesian meta-regressions across 41 randomized trials of CKD progression, we characterized the combined relationship between the treatment effects on the clinical end point (sustained doubling of serum creatinine, GFR <15 ml/min per 1.73 m 2 , or kidney failure) and treatment effects on UACR change and chronic GFR slope after 3 months. We applied the results to the design of Phase 2 trials on the basis of UACR change and chronic GFR slope in combination. RESULTS: Treatment effects on the clinical end point were strongly associated with the combination of treatment effects on UACR change and chronic slope. The posterior median meta-regression coefficients for treatment effects were -0.41 (95% Bayesian Credible Interval, -0.64 to -0.17) per 1 ml/min per 1.73 m 2 per year for the treatment effect on GFR slope and -0.06 (95% Bayesian Credible Interval, -0.90 to 0.77) for the treatment effect on UACR change. The predicted probability of clinical benefit when considering both surrogates was determined primarily by estimated treatment effects on UACR when sample size was small (approximately 60 patients per treatment arm) and follow-up brief (approximately 1 year), with the importance of GFR slope increasing for larger sample sizes and longer follow-up. CONCLUSIONS: In Phase 2 trials of CKD with sample sizes of 100-200 patients per arm and follow-up between 1 and 2 years, combining information from treatment effects on UACR change and GFR slope improved the prediction of treatment effects on clinical end points.

Impact of transitioning to virtual delivery of a cardiovascular health improvement program for Latinos during the COVID-19 pandemic.

BACKGROUND: Community Heart Health Actions for Latinos at Risk (CHARLAR) is a promotora-led cardiovascular disease (CVD) risk-reduction program for socio-demographically disadvantaged Latinos and consists of 11 skill-building sessions. The COVID-19 pandemic has led to worsening health status in U.S. adults and necessitated transition to virtual implementation of the CHARLAR program. METHODS: A mixed-methods approach was used to evaluate virtual delivery of CHARLAR. Changes in health behaviors were assessed through a pre/post program survey. Results from virtual and historical (in-person delivery) were compared. Key informant interviews were conducted with promotoras and randomly selected participants and then coded and analyzed using a thematic approach. RESULTS: An increase in days of exercise per week (+ 1.52), daily servings of fruit (+ 0.60) and vegetables (+ 0.56), and self-reported general health (+ 0.38), were observed in the virtual cohort [all p < 0.05]. A numeric decrease in PHQ-8 (-1.07 p = 0.067) was also noted. The historical cohort showed similar improvements from baseline in days of exercise per week (+ 0.91), daily servings of fruit (+ 0.244) and vegetables (+ 0.282), and PHQ-8 (-1.89) [all p < 0.05]. Qualitative interviews revealed that the online format provided valuable tools supporting positive behavior change. Despite initial discomfort and technical challenges, promotoras and participants adapted and deepened valued relationships through additional virtual support. CONCLUSION: Improved health behaviors and CVD risk factors were successfully maintained through virtual delivery of the CHARLAR program. Optimization of virtual health programs like CHARLAR has the potential to increase reach and improve CVD risk among Latinos.

Cardiovascular Risk Factor Knowledge among Monolingual Hispanics.

Hispanics in the United States have worse cardiovascular disease (CVD) risk factor profiles than non-Hispanic Whites. Cardiovascular health literacy is important for health promotion but is not well characterized among monolingual Spanish-speaking Hispanics outside of health care settings. We recruited Hispanic participants (N=235) from a community-based health fair in Denver, Colorado. A total of 182 participants (77%) completed a subsequent language-congruent telephone survey to assess CVD risk-factor knowledge. Of these, 174 self-identified as monolingual Spanish-speaking, and constituted the analysis cohort. Cardiovascular disease risk knowledge score was defined as the number of established risk factors an individual participant could name (out of 10 pre-specified), and multivariable regression analyses were conducted to determine factors independently associated with knowledge. The mean knowledge score for the cohort was 2.2 ± 1.1 out of 10. This suggests an unmet need for tailored educational interventions beyond simple screening events.

A controlled trial of mobile short message service among participants in a rural cardiovascular disease prevention program.

The statewide Colorado Healthy Heart Solutions (CHHS) program provides cardiovascular disease (CVD) risk factor screening and education to the medically underserved and has been shown to improve CVD risk profiles. We aimed to enhance its effectiveness through addition of a mobile health (mHealth) intervention using SMS messaging (termed Cardio SMS). We conducted a prospective, non-randomized controlled pilot trial of this intervention implemented at 5 rural program sites (number of participants N = 204) compared with a contemporaneous propensity-score matched control group from 14 CHHS sites not receiving the intervention (N = 408) between 2012 and 2014. All participants were free of CVD at baseline, and follow-up time was 12-months. The primary outcome was program engagement, defined as the number of completed interactions with the program during the entire follow-up period. Secondary outcomes were program retention, defined as any interaction during the last two months of the study; change in self-reported healthy behaviors (physical activity, weight loss, smoking cessation, fat intake); and change in CVD risk factors. There were trends for differences between groups across multiple outcomes, but most did not reach statistical significance, except for a greater decrease in self-reported fat intake in the intervention vs. control groups (26.3% vs 10.6%, P = 0.001). In addition, a subset of surveyed participants who viewed the SMS messages as motivating showed greater program retention (P = 0.03). Given the relative ease and scalability of SMS interventions in rural underserved communities, further study of SMS as part of multicomponent strategies for CVD prevention is warranted.

Reduction in Cardiovascular Risk Among Latino Participants in a Community-Based Intervention Linked With Clinical Care.

INTRODUCTION: Community Heart Health Actions for Latinos at Risk is a community health worker-led cardiovascular disease risk reduction program targeting low-income urban Latinos. The impact of community programs linked with clinical care has not been well characterized. METHODS: Community Heart Health Actions for Latinos at Risk provided 12 weeks of lifestyle education. Changes in risk factors were assessed before and after completion. Univariate, bivariate, and multivariate analyses were used to determine factors associated with changes in risk factors. RESULTS: From 2009 to 2013, a total of 1,099 participants were recruited and 768 had risk factors measured at baseline and 12 weeks. All analyses were performed in 2016. In participants with abnormal baseline risk factors, significant (all p<0.001) median reductions in systolic blood pressure (-11 mmHg, n=244); low-density lipoprotein cholesterol (-14 mg/dL, n=201); glucose (-8 mg/dL, n=454); triglycerides (-57 mg/dL, n=242); and Framingham risk score (-2.3%, n=301) were observed. Program completion (eight of 12 classes) was associated with the reduction in low-density lipoprotein cholesterol (p=0.03) and systolic blood pressure (p=0.01). After adjustment, low-density lipoprotein cholesterol reduction was greatest in participants newly prescribed lipid-lowering drugs (-30%, 95% CI= -48, -15). CONCLUSIONS: A community health worker-led intervention lowered cardiovascular disease risk among vulnerable Latinos. Integration with primary care services was an essential program component.

Is 60 the New 80 in Hypertension?

Since the release of the "2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8)", much controversy has ensued over the appropriate systolic blood pressure goal for those over the age of 60 years. This guideline suggested liberalizing the target for this population to <150 mmHg, moving away from previous guidelines suggesting a target of <140 mmHg. While some national quality measures have accepted the new relaxed blood pressure goal, the American Heart Association and American College of Cardiology have not. Recently published data show that millions of adults over 60 years of age would be classified as controlled using a threshold of <150 mmHg, but not with a target of <140 mmHg. In addition, emerging randomized trial evidence suggests that targeting a systolic blood pressure well below 140 mmHg is beneficial in older adults. In light of the improved health and vitality of older adults, and the steady decline in cardiovascular and cerebrovascular mortality over recent decades, we do not think it is in good judgment to liberalize the treatment target in adults less than 80 years of age.

Augmenting Predictive Modeling Tools with Clinical Insights for Care Coordination Program Design and Implementation.

CONTEXT: The Center for Medicare and Medicaid Innovation (CMMI) awarded Denver Health's (DH) integrated, safety net health care system $19.8 million to implement a "population health" approach into the delivery of primary care. This major practice transformation builds on the Patient Centered Medical Home (PCMH) and Wagner's Chronic Care Model (CCM) to achieve the "Triple Aim": improved health for populations, care to individuals, and lower per capita costs. CASE DESCRIPTION: This paper presents a case study of how DH integrated published predictive models and front-line clinical judgment to implement a clinically actionable, risk stratification of patients. This population segmentation approach was used to deploy enhanced care team staff resources and to tailor care-management services to patient need, especially for patients at high risk of avoidable hospitalization. Developing, implementing, and gaining clinical acceptance of the Health Information Technology (HIT) solution for patient risk stratification was a major grant objective. FINDINGS: In addition to describing the Information Technology (IT) solution itself, we focus on the leadership and organizational processes that facilitated its multidisciplinary development and ongoing iterative refinement, including the following: team composition, target population definition, algorithm rule development, performance assessment, and clinical-workflow optimization. We provide examples of how dynamic business intelligence tools facilitated clinical accessibility for program design decisions by enabling real-time data views from a population perspective down to patient-specific variables. CONCLUSIONS: We conclude that population segmentation approaches that integrate clinical perspectives with predictive modeling results can better identify high opportunity patients amenable to medical home-based, enhanced care team interventions.

Health Promotion Text Messaging Preferences and Acceptability Among the Medically Underserved.

The Colorado Healthy Heart Solutions program uses community health workers to provide health promotion and navigation services for participants in medically underserved, predominantly rural areas who are at risk for developing cardiovascular disease. A text messaging program designed to increase participant engagement and adherence to lifestyle changes was pilot tested with English- and Spanish-speaking participants. Preimplementation focus groups with participants informed the development of text messages that were used in a 6-week pilot program. Postimplementation focus groups and interviews then evaluated the pilot program. Participants reported a preference for concise messages received once daily and for positive messages suggesting specific actions that could be feasibly accomplished within the course of the day. Participants also consistently reported the desire for clarity in message delivery and content, indicating that the source of the messages should be easy to recognize, messages should state clearly when participants were expected to respond to the messages, and any responses should be acknowledged. Links to other websites or resources were generally viewed as trustworthy and acceptable, but were preferred for supplementary material only. These results may inform the development of future chronic disease management programs in underserved areas or augment existing programs using text messaging reinforcement.

Effectiveness of a community health worker cardiovascular risk reduction program in public health and health care settings.

OBJECTIVES: We evaluated whether a program to prevent coronary heart disease (CHD) with community health workers (CHWs) would improve CHD risk in public health and health care settings. METHODS: The CHWs provided point-of-service screening, education, and care coordination to residents in 34 primarily rural Colorado counties. The CHWs utilized motivational interviewing and navigated those at risk for CHD into medical care and lifestyle resources. A software application generated a real-time 10-year Framingham Risk Score (FRS) and guideline-based health recommendations while supporting longitudinal caseload tracking. We used multiple linear regression analysis to determine factors associated with changes in FRS. RESULTS: From 2010 to 2011, among 4743 participants at risk for CHD, 53.5% received medical or lifestyle referrals and 698 were retested 3 or more months after screening. We observed statistically significant improvements in diet, weight, blood pressure, lipids, and FRS with the greatest effects among those with uncontrolled risk factors. Successful phone interaction by the CHW led to lower FRS at retests (P = .04). CONCLUSIONS: A CHW-based program within public health and health care settings improved CHD risk. Further exploration of factors related to improved outcomes is needed.

Relation of reduction in urinary albumin excretion to ten-year cardiovascular mortality in patients with type 2 diabetes and systemic hypertension.

Microalbuminuria is one of the strongest predictors of both adverse renal and cardiovascular disease (CVD) outcomes in patients with type 2 diabetes mellitus. Although measurement of urinary albumin excretion (UAE) is widely recommended, limited data are available to suggest that reducing UAE translates into a reduction in long-term cardiovascular mortality, particularly among patients without overt nephropathy, who constitute most patients with type 2 diabetes worldwide. We assessed whether changes in the UAE at 1 year were associated with cardiovascular mortality in 393 patients with hypertension and type 2 diabetes during a 10-year period. On univariate analysis, CVD history, age, diabetes duration, and change in UAE at 1 year were associated with cardiovascular mortality risk (hazard ratio 2.60 for those with CVD history, 95% confidence interval [CI] 1.47 to 4.62; hazard ratio 1.59 per 10 years of diabetes duration, 95% CI 1.12 to 2.25; and hazard ratio 1.49 per log UAE increase, 95% CI 1.13 to 1.96). In a stepwise Cox regression model that included baseline UAE and CVD history, the 10-year predicted mortality of those with a decrease in UAE of 2 logs at 1 year was 4.7% (95% CI 1.4% to 7.8%). For those with an increase in UAE of 2 logs at 1 year, it was 24.5% (95% CI 10.1% to 36.5%). In conclusion, these data support current guideline recommendations to screen for UAE in all patients with type 2 diabetes, even in the absence of nephropathy, and suggest that serial UAE measurements even after the initiation of antihypertensive therapy has prognostic value independent of traditional cardiovascular risk factors.

Care by cell phone: text messaging for chronic disease management.

OBJECTIVES: To assess the feasibility of engaging adults with diabetes in self management behaviors between clinic visits by using cell phone text messaging to provide blood sugar measurement prompts and appointment reminders. STUDY DESIGN: Quasi-experimental pilot among adult diabetic patients with cell phones who receive regular care at a federally qualified community health center in Denver, Colorado, which serves a population that is predominantly either uninsured (41%) or on Medicaid or Medicare (56%). METHODS: Patients (N = 47) received text message prompts over a 3-month period. Blood sugar readings were requested 3 times per week (Monday, Wednesday, and Friday). Reminders were sent 7, 3, and 1 day(s) before each scheduled appointment. Acknowledgments were returned for all patient-sent messages. Focus groups were conducted in English and Spanish with selected patients (n = 8). RESULTS: Patients of all ages were active participants. Correctly formatted responses were received for 67.3% of 1585 prompts. More than three-fourths (79%) of the cohort responded to more than 50% of their prompts. The appointment analysis was underpowered to detect significant changes in attendance. Participants reported increased social support, feelings that the program "made them accountable," and increased awareness of health information. Two-thirds (66%) of patients provided glucose readings when prompted during the study, compared with 12% at 2 preceding clinic visits. CONCLUSIONS: For certain patients, cell phone-based text messaging may enhance chronic disease management support and patient-provider communications beyond the clinic setting.

Nurse-run, telephone-based outreach to improve lipids in people with diabetes.

BACKGROUND: There is a need for randomized, prospective trials of case management interventions with resource utilization analyses. OBJECTIVES: To determine whether algorithm-driven telephone care by nurses improves lipid control in patients with diabetes. DESIGN: Prospective, randomized, controlled trial. PARTICIPANTS: Adults with diabetes at a federally funded community health center were randomly assigned to intervention (n = 381) or usual-care (n = 381) groups. INTERVENTIONS: Nurses independently initiated and titrated lipid therapy and promoted behavioral change through motivational interviewing and self-management techniques. Other parameters of diabetes care were addressed based on time constraints. MAIN MEASURES: The primary outcome was the proportion of patients with a low-density lipoprotein (LDL) less than 100 mg/dL. Secondary outcomes included the number of hospital admissions, total hospital charges per patient, and the proportion of patients meeting other lipid, glycemic, and blood pressure guidelines. KEY RESULTS: The percent of patients with an LDL < 100 mg/dL increased from 52.0% to 58.5% in the intervention group and decreased from 55.6% to 46.7% in the control group (P < .01). Average cost per patient to the healthcare system was less for the intervention group ($6600 vs $9033, P = .03). Intervention patients trended toward fewer hospital admissions (P = .06). The intervention did not affect glycemic and blood pressure outcomes. CONCLUSIONS: Nurses can improve lipid control in patients with diabetes in a primarily indigent population through telephone care using moderately complex algorithms, but a more targeted approach is warranted. Telephone-based outreach may decrease resource utilization, but more study is needed.

Impact of cardiovascular disease guideline dissemination on provider knowledge.

INTRODUCTION: Provider characteristics associated with higher cardiovascular disease (CVD) knowledge and learning through clinical practice guidelines (CPG) dissemination are not well understood. METHODS: A baseline knowledge survey was distributed to licensed primary care practitioners. A CPG was then distributed following 6-weeks later by a repeat survey to assess proportion reading the CPG and changes in an aggregate knowledge score. The authors examined provider characteristics as predictors of CPG review and knowledge. Changes in CVD knowledge and specific CVD knowledge deficits were assessed. RESULTS: Of 1415 providers, 59% (830) completed the initial survey, 46% (651) completed the survey after CPG dissemination and 37% (523) completed both. The weighted percentage of CPG review was 51% (95% CI: 47%-55%) and was higher among midlevel providers (63% versus 44%, P < 0.001) and those in practice >5 years (53% versus 40%, P=0.017). Overall, baseline knowledge score was 71.2% and improved to 72.2% (P=0.038). Improvement in knowledge score was greater among midlevel providers (mean increase 2.4%, 95% CI: 1.0%-4.0%). Paradoxically, those in practice >5 years exhibited a trend toward lower improvements (2.2% versus 1.1%, P=0.08). CONCLUSIONS: Direct dissemination of a CPG resulted in a moderate rate of review, yet only small improvements in knowledge. This suggests that CPG dissemination alone is inadequate to substantively improve provider knowledge, although midlevel providers were more likely to read the CPG and increase their knowledge score. Multicomponent education strategies tailored to provider characteristics may be more effective improving knowledge.

Reducing cardiovascular disease risk using patient navigators, Denver, Colorado, 2007-2009.

INTRODUCTION: Early identification of cardiovascular disease (CVD) risk is important to reach people in need of treatment. At-risk patients benefit from behavioral counseling in addition to medical therapy. The objective of this study was to determine whether enhanced counseling, using patient navigators trained to counsel patients on CVD risk-reduction strategies and facilitate patient access to community-based lifestyle-change services, reduced CVD risk among at-risk patients in a low-income population. METHODS: We compared clinical characteristics at baseline and 12-month follow-up among 340 intervention and 340 comparison patients from community health centers in Denver, Colorado, between March 2007 and June 2009; all patients had a Framingham risk score (FRS) greater or equal to 10% at baseline. The intervention consisted of patient-centered counseling by bilingual patient navigators. At baseline and at 6-month and 12-month follow-up, we assessed health behaviors of intervention participants. We used an intent-to-treat approach for all analyses and measured significant differences by χ(2) and t tests. RESULTS: We found significant differences in several clinical outcomes. At follow-up, the mean FRS was lower for the intervention group (mean FRS, 15%) than for the comparison group (mean FRS, 16%); total cholesterol was lower for the intervention group (mean total cholesterol, 183 mg/dL) than for the comparison group (mean total cholesterol, 197 mg/dL). Intervention participants reported significant improvements in some health behaviors at 12-month follow-up, especially nutrition-related behaviors. Behaviors related to tobacco use and cessation attempts did not improve. CONCLUSION: Patient navigators may provide some benefit in reducing risk of CVD in a similar population.

Pulse wave velocity and carotid atherosclerosis in white and Latino patients with hypertension.

BACKGROUND: Preventive cardiology has expanded beyond coronary heart disease towards prevention of a broader spectrum of cardiovascular diseases. Ethnic minorities are at proportionately greater risk for developing extracoronary vascular disease including heart failure and cerebrovascular disease. METHODS: We performed a cross sectional study of Latino and White hypertension patients in a safety-net healthcare system. Framingham risk factors, markers of inflammation (hsCRP, LPpLA2), arterial stiffness (Pulse wave velocity, augmentation index, and central aortic pressure), and endothelial function (brachial artery flow-mediated dilatation) were measured. Univariate and multivariable associations between these parameters and an index of extracoronary atherosclerosis (carotid intima media thickness) was performed. RESULTS: Among 177 subjects, mean age was 62 years, 67% were female, and 67% were Latino. In univariate analysis, markers associated with carotid intima media thickness (IMT) at p<0.25 included pulse wave velocity (PWV), augmentation index (AIx), central aortic pressure (cAP), and LpPLA2 activity rank. However, AIx, cAP, and LpPLA2 activity were not significantly associated with carotid IMT after adjusting for Framingham risk factors (all p>.10). Only PWV retained a significant association with carotid IMT independent of the Framingham general risk profile parameters (p=.016). No statistically significant interactions between Framingham and other independent variables with ethnicity (all p>.05) were observed. CONCLUSION: In this safety net cohort, PWV is a potentially useful adjunctive atherosclerotic risk marker independent of traditional risk factors and irrespective of ethnicity.

Prediction of cardiovascular death in racial/ethnic minorities using Framingham risk factors.

BACKGROUND: Risk factors for cardiovascular disease (CVD) derived from the Framingham study are widely used to guide preventive efforts. It remains unclear whether these risk factors predict CVD death in racial/ethnic minorities as well as they do in the predominately white Framingham cohorts. METHODS AND RESULTS: Using linked data from the National Health and Nutrition Examination Survey III (1988 to 1994) and the National Death Index, we developed Cox proportional hazard models that predicted time to cardiovascular death separately for non-Hispanic white (NHW), non-Hispanic black (NHB), and Mexican American (MA) participants ages 40 to 80 years with no previous CVD. We compared calibration and discrimination for the 3 racial/ethnic models. We also plotted predicted 10-year CVD mortality by age for the three racial/ethnic groups while holding other risk factors constant (3437 NHW, 1854 NHB, and 1834 MA subjects met inclusion criteria). Goodness-of-fit chi(2) tests demonstrated adequate calibration for the 3 models (NHW, P=0.49; NHB, P=0.47; MA; P=0.55), and areas under the receiver operating characteristic curves demonstrated similar discrimination (c-statistics: NHW, 0.8126; NHB, 0.7679; and MA, 0.7854). Older age was more strongly associated with CVD mortality in NHWs (hazard ratio, 3.37; 95% CI, 2.80 to 4.05) than NHBs (hazard ratio, 2.29; 95% CI, 1.91 to 2.75) and was intermediate in MAs (hazard ratio, 2.46; 95% CI, 1.95 to 3.11). Predicted 10-year mortality rate was highest for NHBs across all age ranges and was higher for MAs than NHWs until late in the seventh decade. CONCLUSIONS: Framingham risk factors predict CVD mortality equally well in NHWs, NHBs, and MAs, but the strength of the association between individual risk factors and CVD mortality differs by race and ethnicity. When other risk factors are held constant, minority individuals are at higher risk of CVD mortality at younger ages than NHWs.