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1.
J Card Fail ; 18(8): 600-6, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22858074

ABSTRACT

BACKGROUND: Fixed-dose combined isosorbide dinitrate/hydralazine (FDC I/H) significantly improved outcomes in patients with advanced heart failure (HF) receiving background neurohormonal therapy in the African-American Heart Failure Trial (A-HeFT). In this analysis, we investigated treatment effects by age <65 or ≥65 years. METHODS AND RESULTS: Time-to-event curves were produced by the Kaplan-Meier method. Hazard ratios were calculated with the Cox proportional hazards model. Baseline characteristics showed that patients ≥65 years old had less hypertensive and more ischemic HF, better quality of life (QoL) scores, higher plasma B-type natriuretic peptide and creatinine levels, and received less background neurohormonal therapy. Kaplan-Meier curves showed that FDC I/H improved mortality and event-free survival in elderly patients. The hazard ratios for mortality, first heart failure hospitalization, and event-free survival (both unadjusted and adjusted for baseline differences), were similar quantitatively and in direction of effect in both age groups. CONCLUSIONS: In A-HeFT, FDC I/H improved outcomes in HF patients aged <65 or ≥65 years, despite significant baseline differences between these age groups. Patients aged ≥65 years, a group at greater mortality risk, had the greatest survival benefit from FDC I/H.


Subject(s)
Black or African American/statistics & numerical data , Heart Failure/drug therapy , Hydralazine/therapeutic use , Isosorbide Dinitrate/therapeutic use , Nitric Oxide Donors/therapeutic use , Vasodilator Agents/therapeutic use , Age Factors , Aged , Aging , Double-Blind Method , Drug Therapy, Combination , Female , Health Status Indicators , Heart Failure/epidemiology , Heart Failure/mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Quality of Life/psychology , Time , Treatment Outcome , United States/epidemiology
2.
J Card Fail ; 16(1): 9-16, 2010 Jan.
Article in English | MEDLINE | ID: mdl-20123313

ABSTRACT

BACKGROUND: Low health literacy compromises patient safety, quality health care, and desired health outcomes. Specifically, low health literacy is associated with decreased knowledge of one's medical condition, poor medication recall, nonadherence to treatment plans, poor self-care behaviors, compromised physical and mental health, greater risk of hospitalization, and increased mortality. METHODS: The health literacy literature was reviewed for: definitions, scope, risk factors, assessment, impact on health outcomes (cardiovascular disease and heart failure), and interventions. Implications for future research and for clinical practice to address health literacy in heart failure patients were summarized. RESULTS: General health literacy principles should be applied to patients with heart failure, similar to others with chronic conditions. Clinicians treating patients with heart failure should address health literacy using five steps: recognize the consequences of low health literacy, screen patients at risk, document literacy levels and learning preferences, and integrate effective strategies to enhance patients' understanding into practice. CONCLUSION: Although the literature specifically addressing low health literacy in patients with heart failure is limited, it is consistent with the larger body of health literacy evidence. Timely recognition of low health literacy combined with tailored interventions should be integrated into clinical practice.


Subject(s)
Health Literacy/methods , Heart Failure/therapy , Patient Care/methods , Societies, Medical , Health Knowledge, Attitudes, Practice , Health Literacy/standards , Heart Failure/diagnosis , Humans , Patient Care/standards , Patient Education as Topic/methods , Patient Education as Topic/standards , Societies, Medical/standards , United States
3.
Circulation ; 115(13): 1747-53, 2007 Apr 03.
Article in English | MEDLINE | ID: mdl-17372175

ABSTRACT

BACKGROUND: We previously reported that the fixed-dose combination of isosorbide dinitrate and hydralazine hydrochloride (FDC I/H) significantly decreased the risk of all-cause death and first hospitalization for heart failure (HF) and improved quality of life in patients with New York Heart Association class III or IV heart failure in the African-American Heart Failure Trial (A-HeFT). The current analyses further define the effect of FDC I/H on the timing of event-free survival (mortality or first hospitalization for HF) and time to first hospitalization for HF, as well as effects by subgroups and effects on cause-specific mortality. METHODS AND RESULTS: Kaplan-Meier analyses of the 1050 A-HeFT patients on standard neurohormonal blockade demonstrated that FDC I/H produced a 37% improvement in event-free survival (P<0.001) and a 39% reduction in the risk for first hospitalization for HF (P<0.001). These benefits appeared to emerge early (at approximately 50 days of treatment) and were sustained through the duration of the trial. Subgroup analyses of treatment effect by age, sex, baseline blood pressure, history of chronic renal insufficiency, presence of diabetes mellitus, cause of HF, and baseline medication usage demonstrated consistent beneficial effect of FDC I/H on the primary composite score and event-free survival across all subgroups. Mortality from pump failure was reduced by 75% (P=0.012). CONCLUSIONS: FDC I/H treatment of black patients with moderate to severe HF who were taking neurohormonal blockers produced early and sustained significant improvement in event-free survival and hospitalization for HF in the A-HeFT cohort, with significant reduction in mortality from cardiovascular and pump failure deaths. The treatment effects on the primary composite end point and event-free survival were consistent across subgroups.


Subject(s)
Heart Failure/drug therapy , Hydralazine/therapeutic use , Isosorbide Dinitrate/therapeutic use , Nitric Oxide Donors/therapeutic use , Vasodilator Agents/therapeutic use , Adult , Black or African American/statistics & numerical data , Aged , Arthralgia/chemically induced , Biomarkers/blood , Cardiovascular Agents/therapeutic use , Cause of Death , Disease-Free Survival , Dizziness/chemically induced , Double-Blind Method , Drug Combinations , Heart Failure/epidemiology , Heart Failure/etiology , Heart Failure/psychology , Heart Transplantation/statistics & numerical data , Hospitalization/statistics & numerical data , Humans , Hydralazine/administration & dosage , Hypotension/chemically induced , Isosorbide Dinitrate/administration & dosage , Isosorbide Dinitrate/adverse effects , Kaplan-Meier Estimate , Middle Aged , Mortality , Natriuretic Peptide, Brain/blood , Nitric Oxide Donors/administration & dosage , Proportional Hazards Models , Quality of Life , Surveys and Questionnaires , Treatment Outcome , Vasodilator Agents/administration & dosage , Vasodilator Agents/adverse effects
4.
J Am Coll Cardiol ; 48(11): 2263-7, 2006 Dec 05.
Article in English | MEDLINE | ID: mdl-17161257

ABSTRACT

OBJECTIVES: Previous trials testing isosorbide dinitrate/hydralazine (I/H) were performed in all-male study cohorts, and thus the efficacy of I/H in women was unknown; 40% of the A-HeFT (African-American Heart Failure Trial) cohort were women. We therefore compared outcomes by gender and treatment. BACKGROUND: Fixed-dose combined I/H significantly reduced mortality and heart failure hospitalizations and improved quality of life in 1,050 black patients with heart failure treated with background neurohormonal blockade. Previous trials testing I/H were done in all-male study cohorts, and thus the efficacy of I/H in women was unknown. METHODS: Baseline characteristics and medications were compared between men and women by I/H and placebo treatment. Survival, time to first heart failure hospitalization, change in quality of life, and event-free survival were compared by gender and treatment. RESULTS: At baseline, women had lower hemoglobin and creatinine levels; less renal insufficiency; and higher body mass indexes, diabetes prevalence, and systolic blood pressures; but worse quality of life scores. All-cause mortality was lower in women than in men treated with I/H but without significant treatment interaction by gender. The primary composite score, which weighted mortality, first heart failure hospitalization, and change in quality of life at 6 months, was similarly improved by I/H in men and women. First heart failure hospitalization and event-free survival (time to death or first heart failure hospitalization) were similarly improved in both genders. CONCLUSIONS: Fixed-dose I/H improved heart failure outcomes in both men and women in A-HeFT. The I/H significantly improved the primary composite score and event-free survival as well as reduced the risk of first heart failure hospitalizations similarly in both genders. The I/H had a slightly greater mortality benefit in women, but without a significant treatment interaction by gender.


Subject(s)
Black or African American , Cardiac Output, Low/drug therapy , Cardiac Output, Low/ethnology , Hydralazine/therapeutic use , Isosorbide Dinitrate/therapeutic use , Sex Factors , Vasodilator Agents/therapeutic use , Adult , Aged , Cardiac Output, Low/mortality , Cardiac Output, Low/physiopathology , Drug Therapy, Combination , Female , Hospitalization , Humans , Male , Middle Aged , Quality of Life , Randomized Controlled Trials as Topic , Survival Analysis , Time Factors , Treatment Outcome
5.
N Engl J Med ; 351(20): 2049-57, 2004 Nov 11.
Article in English | MEDLINE | ID: mdl-15533851

ABSTRACT

BACKGROUND: We examined whether a fixed dose of both isosorbide dinitrate and hydralazine provides additional benefit in blacks with advanced heart failure, a subgroup previously noted to have a favorable response to this therapy. METHODS: A total of 1050 black patients who had New York Heart Association class III or IV heart failure with dilated ventricles were randomly assigned to receive a fixed dose of isosorbide dinitrate plus hydralazine or placebo in addition to standard therapy for heart failure. The primary end point was a composite score made up of weighted values for death from any cause, a first hospitalization for heart failure, and change in the quality of life. RESULTS: The study was terminated early owing to a significantly higher mortality rate in the placebo group than in the group given isosorbide dinitrate plus hydralazine (10.2 percent vs. 6.2 percent, P=0.02). The mean primary composite score was significantly better in the group given isosorbide dinitrate plus hydralazine than in the placebo group (-0.1+/-1.9 vs. -0.5+/-2.0, P=0.01; range of possible values, -6 to +2), as were its individual components (43 percent reduction in the rate of death from any cause [hazard ratio, 0.57; P=0.01] 33 percent relative reduction in the rate of first hospitalization for heart failure [16.4 percent vs. 22.4 percent, P=0.001], and an improvement in the quality of life [change in score, -5.6+/-20.6 vs. -2.7+/-21.2, with lower scores indicating better quality of life; P=0.02; range of possible values, 0 to 105]). CONCLUSIONS: The addition of a fixed dose of isosorbide dinitrate plus hydralazine to standard therapy for heart failure including neurohormonal blockers is efficacious and increases survival among black patients with advanced heart failure.


Subject(s)
Black People , Heart Failure/drug therapy , Heart Failure/ethnology , Hydralazine/therapeutic use , Isosorbide Dinitrate/therapeutic use , Nitric Oxide Donors/therapeutic use , Vasodilator Agents/therapeutic use , Adult , Aged , Double-Blind Method , Drug Combinations , Drug Therapy, Combination , Female , Heart Failure/mortality , Humans , Hydralazine/adverse effects , Isosorbide Dinitrate/adverse effects , Male , Middle Aged , Nitric Oxide Donors/adverse effects , Quality of Life , Survival Analysis , Treatment Outcome , Vasodilator Agents/adverse effects
6.
J Card Fail ; 8(3): 128-35, 2002 Jun.
Article in English | MEDLINE | ID: mdl-12140804

ABSTRACT

BACKGROUND: Hydralazine and isosorbide dinitrate combination (H+ISDN), angiotensin-converting enzyme inhibitors, and beta-blockers have improved outcomes in heart failure (HF). Analysis of previous trials has shown that H+ISDN appears especially beneficial in African American patients. METHODS AND RESULTS: The African-American Heart Failure Trial (A-HeFT) is double-blind, placebo-controlled, and includes African American patients with stable New York Heart Association Class III-IV HF on standard therapy. Patients must have prior HF-related events and left ventricular ejection fraction (LVEF) < or = 35% or LVEF <45% with left ventricular internal diastolic dimension >2.9 cm/m(2). Randomization to addition of placebo or BiDil (Nitro Med, Inc., Bedford, MA), a fixed combination of H+ISDN, is stratified for beta-blocker usage. All patients are treated and followed until the last patient entered completes 6 months of follow-up. The primary efficacy endpoint is a composite score including quality of life, death, and hospitalization for HF. At least 600 patients will be randomized; the first was randomized in June 2001. CONCLUSIONS: In addition to providing additional information on BiDil efficacy in HF, A-HeFT is the first HF trial aimed at a selected subgroup of patients and the first to use a new composite HF score as its primary efficacy endpoint.


Subject(s)
Black People , Heart Failure/drug therapy , Hydralazine/therapeutic use , Isosorbide Dinitrate/therapeutic use , Vasodilator Agents/therapeutic use , Adolescent , Adult , Aged , Double-Blind Method , Drug Combinations , Female , Heart Failure/diagnosis , Humans , Informed Consent , Male , Middle Aged , Patient Selection , Research Design , Treatment Outcome , Ventricular Dysfunction, Left/drug therapy
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