Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study).

BACKGROUND: Inadequate blood pressure control and poor adherence to treatment remain among the major limitations in the management of hypertensive patients, particularly of those at high risk of cardiovascular events. Preliminary evidence suggests that home blood pressure telemonitoring (HBPT) might help increasing the chance of achieving blood pressure targets and improve patient's therapeutic adherence. However, all these potential advantages of HBPT have not yet been fully investigated. METHODS/DESIGN: The purpose of this open label, parallel group, randomized, controlled study is to assess whether, in patients with high cardiovascular risk (treated or untreated essential arterial hypertension--both in the office and in ambulatory conditions over 24 h--and metabolic syndrome), long-term (48 weeks) blood pressure control is more effective when based on HBPT and on the feedback to patients by their doctor between visits, or when based exclusively on blood pressure determination during quarterly office visits (conventional management (CM)). A total of 252 patients will be enrolled and randomized to usual care (n = 84) or HBPT (n = 168). The primary study endpoint will be the rate of subjects achieving normal daytime ambulatory blood pressure targets (< 135/85 mmHg) 24 weeks and 48 weeks after randomization. In addition, the study will assess the psychological determinants of adherence and persistence to drug therapy, through specific psychological tests administered during the course of the study. Other secondary study endpoints will be related to the impact of HBPT on additional clinical and economic outcomes (number of additional medical visits, direct costs of patient management, number of antihypertensive drugs prescribed, level of cardiovascular risk, degree of target organ damage and rate of cardiovascular events, regression of the metabolic syndrome). DISCUSSION: The TELEBPMET Study will show whether HBPT is effective in improving blood pressure control and related medical and economic outcomes in hypertensive patients with metabolic syndrome. It will also provide a comprehensive understanding of the psychological determinants of medication adherence and blood pressure control of these patients. TRIAL REGISTRATION: Clinical Trials.gov: NCT01541566.

Factors associated with glomerular hyperfiltration in the early stage of hypertension.

BACKGROUND: Glomerular hyperfiltration predicts development of nephropathy in hypertension but the factors responsible for increased glomerular filtration rate (GFR) are not well known. Aim of this study was to examine which clinical variables influence GFR in the early stage of hypertension. METHODS: Participants were 1,106 young-to-middle-age hypertensive adults with creatinine clearance >60 ml/min/1.73 m(2). Clinic and ambulatory blood pressures (BPs) were measured and the difference between clinic and 24-h systolic BP was defined as the white-coat effect (WCE). In 606 participants, 24-h urinary epinephrine and norepinephrine were also measured. Glomerular hyperfiltration, defined as a GFR ≥150 ml/min/1.73 m(2), was present in 201 subjects. RESULTS: Patients' mean age was 33.1 ± 8.5 years and office BP was 146 ± 10.5/94 ± 5.0 mm Hg. In multivariable linear regression, significant predictors of GFR were younger age (P < 0.0001), male gender (P < 0.0001), 24-h systolic BP (P = 0.0001), body mass (P < 0.0001), WCE (P = 0.02), log-epinephrine (P = 0.01), and coffee use (P < 0.01). In a logistic model, independent predictors of glomerular hyperfiltration were obesity (odds ratio, 95% confidence interval = 6.1, 3.8-9.8), male gender (2.9, 1.8-4.9), age <33 years (2.1, 1.5-3.1), ambulatory hypertension (2.0, 1.4-3.0), WCE >15 mm Hg (1.6, 1.1-2.3), heavy coffee use (2.0, 1.1-3.8), and epinephrine >25 mcg/24 h (1.9, 1.2-3.1). CONCLUSIONS: The novel finding of this study is that hyper-reactivity to stress, as determined by urinary epinephrine level and WCE, and coffee use contribute to determining glomerular hyperfiltration in the early stage of hypertension. Our data may help to identify a subset of patients with glomerular hyperfiltration, who may be at increased risk of chronic kidney disease and may benefit from antihypertensive treatment.

Biofeedback-assisted cardiovascular control in hypertensives exposed to emotional stress: a pilot study.

The study was aimed at examining the effect of a short Heart Rate-Biofeedback (HR-BF) protocol on systolic (SBP) and diastolic (DBP) blood pressure levels and BP emotional reactivity. Twenty-four unmedicated outpatients with pre- and stage 1 hypertension, were randomly assigned to active treatment (BF-Training) or control (BP-Monitoring) group. Subjects in BF-Training Group underwent four BF sessions. Guided imagery of stressful events was introduced during sessions 3 and 4. Control participants self-monitored their BP at home for 4 weeks. Subjects in both groups performed an emotional Speech Test before and after the training (or monitoring) period. SBP and mean arterial pressure responses to the emotional Speech Test were significantly smaller after the BF-training than the BP-monitoring. Moreover, clinic SBP and DBP were significantly reduced by about 10 mmHg in BF-Training Group, whereas they remained unchanged in control group. Self-monitored BP decreased significantly in the active treatment group and not in control group. A short BF-training, including guided imagery of stressful events, was effective in reducing BP reactions to a psychosocial stressor. BP measured in the clinic, and self-monitored at home were also significantly reduced in the BF-Training Group. HR-BF appears to be a suitable intervention for hypertensive patients, mostly when BP increase is associated with emotional activation.

Accuracy of a single rigid conical cuff with standard-size bladder coupled to an automatic oscillometric device over a wide range of arm circumferences.

Although the upper arm has the shape of a truncated cone, cylindrical cuffs and bladders are currently used for blood pressure (BP) measurement. The aims of this study were to describe upper arm characteristics and to test the accuracy of a standard adult-size conical cuff coupled to an oscillometric device over a wide range of arm circumferences. Arm characteristics were studied in 142 subjects with arm circumferences ranging from 22 to 45 cm (study 1). In a subset of 33 subjects with the same range of arm circumferences, a rigid conical cuff with standard-size bladder (12.6 × 24.0 cm) and a rigid cylindrical cuff (13.3 × 24.0 cm), both coupled to a Microlife BP A100 device, were tested according to the requirements of the protocol of the European Society of Hypertension (ESH; study 2). Study 1. In all subjects, upper-arm shape was tronco-conical with slant angles ranging from 89.5° to 82.2°. In a multiple linear regression analysis, only arm circumference was an independent predictor of conicity (P<0.001). Study 2. The rigid conical cuff passed all three phases of the ESH protocol for systolic and diastolic BPs. Mean device-observer BP differences obtained with the conical cuff were unrelated to arm circumference. When the rigid cylindrical cuff was used, ESH criteria were not satisfied, and the cuff overestimated systolic BPs in subjects with large arms. BP can be measured accurately with the use of a standard-size rigid conical cuff coupled to a BP A100 device for a wide range of arm circumferences.

Validation of Panasonic EW3106 and EW3109 devices for blood pressure measurement according to the International Protocol.

To determine the accuracy of the EW3106 and EW3109 devices for blood pressure measurement at the upper arm developed by Panasonic. Device evaluations were performed according to the European Society of Hypertension requirements, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg, or more. Both devices passed all three phases of the protocol for systolic blood pressure (SBP) and diastolic blood pressure (DBP). Mean blood pressure difference between the EW3106 monitor and observers was -0.9+/-5.8 mmHg for SBP and 0.1+/-4.8 mmHg for DBP. Mean differences for the EW3109 monitor were -2.1+/-6.5 mmHg and -0.3+/-4.7 mmHg, respectively. In multivariable analyses, the SBP and DBP discrepancies between both devices and observers were unrelated to age and arm circumference, and were inversely related to blood pressure level. These data show that the Panasonic EW3106 and EW 3109 monitors satisfy the recommended European Society of Hypertension accuracy levels for SBP and DBP.

Validation of the Visomat Comfort form device for home blood pressure measurement according to the International Protocol.

To evaluate the accuracy of the UEBE Visomat Comfort form device for home blood pressure measurement tested following the recommendations of the International Protocol of the European Society of Hypertension. Device evaluation was performed in 33 participants with a mean +/- standard deviation age of 56.5+/-18.3 years (range 30-91 years). Their systolic blood pressure (SBP) was 143.6+/-25.3 mmHg (range 94-180 mmHg), diastolic blood pressure (DBP) was 88.8+/-15.4 mmHg (range 64-116 mmHg), and upper arm circumference was 30.2+/-3.2 cm (range 24.5-39.0 cm). BP measurements were performed in the sitting position. The Visomat Comfort form passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean BP differences for the Visomat Comfort form (device-observer) were -2.5+/-5.9 mmHg for SBP and -2.4+/-5.4 mmHg for DBP. Similar device-observer differences were observed in the participants divided into two subgroups according to whether their arm circumference was above or below the median in the group. In conclusion, these results indicate that the UEBE Visomat Comfort form monitor can be recommended for clinical use in the adult population over a wide range of arm circumferences.

Accuracy of the BP A100 blood pressure measuring device coupled with a single cuff with standard-size bladder over a wide range of arm circumferences.

The objective of this study was to determine the accuracy of the Microlife BP A100 blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The BP A100 model is designed to provide accurate blood pressure measurements over a wide range of arm circumferences using a single cuff with standard-size bladder. Device evaluation was performed on 33 patients with a mean +/- SD age of 59 +/- 19 years (range 30-89 years). Their systolic blood pressure (SBP) was 143 +/- 23 mmHg (range 108-180 mmHg), diastolic blood pressure (DBP) was 87 +/- 16 mmHg (range 60-108 mmHg), and arm circumference was 31 +/- 4 cm (range 22-42 cm). In nine patients, the arm circumference was at least 33 cm. Blood pressure measurements were performed in the sitting position. The BP A100 passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences between device and observer were -2.9 +/- 4.9 mmHg for SBP and -2.6 +/- 4.6 mmHg for DBP. Similar device-observer differences were observed in the patients divided into two subgroups according to whether their arm circumference was above or below the median in the group. In conclusion, the present results indicate that the Microlife BP A100 monitor coupled with a single cuff with standard size bladder provides accurate blood pressure readings over a wide range of arm circumferences.

CYP1A2 genotype modifies the association between coffee intake and the risk of hypertension.

OBJECTIVES: The longitudinal relationship between coffee use and hypertension is still controversial. Cytochrome P450 1A2 (CYP1A2) is the main responsible enzyme for the metabolism of caffeine. The aim of the present study was to investigate the effect of coffee intake on the risk of developing hypertension needing antihypertensive treatment in individuals stratified by CYP1A2 genotype. DESIGN: We assessed prospectively 553 young White individuals screened for stage 1 hypertension. Coffee intake was ascertained from regularly administered questionnaires. Incident physician-diagnosed hypertension was the outcome measure. Genotyping of CYP1A2 SNP was performed by real time PCR. RESULTS: During a median follow-up of 8.2 years, 323 individuals developed hypertension. For carriers of the slow *1F allele (59%), hazard ratios of hypertension from multivariable Cox analysis were 1.00 in abstainers (reference), 1.72 (95%CI, 1.21-2.44) in moderate coffee drinkers (P = 0.03), and 3.00 (1.53-5.90) in heavy drinkers (P = 0.001). In contrast, hazard ratios for coffee drinkers with the rapid *1A/*1A genotype were 0.80 (0.52-1.23, P = 0.29) for moderate drinkers and 0.36 (0.14-0.89, P = 0.026) for heavy drinkers. In a two-way ANCOVA, a gene x coffee interactive effect was found on follow-up changes in systolic (P = 0.000) and diastolic (P = 0.007) blood pressure. Urinary epinephrine was higher in coffee drinkers than abstainers but only among individuals with slow *1F allele (P = 0.001). CONCLUSION: These data show that the risk of hypertension associated with coffee intake varies according to CYP1A2 genotype. Carriers of slow *1F allele are at increased risk and should thus abstain from coffee, whereas individuals with *1A/*1A genotype can safely drink coffee.

Validation of Microlife BP W100 wrist device assessed according to the European Society of Hypertension and the British Hypertension Society protocols.

The objective of this study was to determine the accuracy of the Microlife BP W100 device for blood pressure measurement. The device evaluations were performed in 85 participants, by using both the protocol of the European Society of Hypertension (ESH) and the protocol of the British Hypertension Society (BHS). Initially, the data from 33 participants were examined according to the ESH protocol. Furthermore, 52 participants were then enrolled to fulfill the BHS protocol requirements. In all participants, sequential same arm measurements were made by two trained observers. The device passed all three phases of the ESH protocol for systolic blood pressure (SBP) and diastolic blood pressure (DBP) and was graded A according to the criteria of the BHS protocol for both SBP and DBP. The A/A grade was achieved in low (<130/80 mmHg), medium (130-160/80-100 mmHg) and high (>160/100 mmHg) blood pressure categories. Mean blood pressure difference between BP W100 and observers in the 85 participants was 0.1+/-5.3 mmHg for SBP and 1.1+/-3.4 mmHg for DBP, and thus, the device also met the requirements of the Association for the Advancement of Medical Instrumentation. In conclusion, these data show that the Microlife BP W100 wrist monitor satisfied the recommended ESH accuracy levels and achieved A/A grade of the BHS protocol across a wide range of blood pressure.

Validation of the visocor HM40 wrist blood pressure measuring device according to the International Protocol.

The objective of this study was to determine the accuracy of the UEBE visocor HM40 device for blood pressure measurement at the wrist, tested according to the requirements of the International Protocol of the European Society of Hypertension (ESH). Device evaluation was performed in 33 patients whose age and blood pressure were within the intervals required by the ESH protocol. Their mean +/- SD age was 53.2 +/- 15.5 years (range 30-85 years), systolic blood pressure (SBP) was 142.8 +/- 21.8 mmHg (range 108-178 mmHg), diastolic blood pressure (DBP) was 87.0 +/- 15.4 mmHg (range 62-112 mmHg), and wrist circumference was 18.7 +/- 2.7 cm (range 15.5-21.5 cm). During the measurements, which were performed in the supine position, the patient's wrist was kept extended at the heart level with a support under the forearm. In total, 45 measurements were available for analysis in the first phase of the validation process, and 99 measurements in the second phase. The visocor HM40 passed all three phases of the ESH protocol for SBP and DBP. Mean blood pressure differences for the visocor HM40 monitor (device-observer) were -2.0 +/- 5.0 mmHg for SBP and -1.7 +/- 5.3 mmHg for DBP, respectively. These data show that the UEBE visocor HM40 wrist monitor met the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Natural history of hypertension subtypes in young and middle-age adults.

BACKGROUND: The evolution of hypertension (HT) subtypes in young-to-middle-age subjects is unclear. METHODS: We did a prospective study in 1,141 participants aged 18-45 years from the HARVEST study screened for stage 1 HT, and 101 nonhypertensive subjects of control during a median follow-up of 72.9 months. RESULTS: At baseline, 13.8% of the subjects were classified as having isolated systolic HT (ISH), 24.8% as having isolated diastolic HT (IDH), and 61.4% as having systolic-diastolic HT (SDH). All hypertensive groups developed sustained HT (clinic blood pressure > or =140/90 mm Hg from two consecutive visits occurring at least after > or =6 months of observation) more frequently than nonhypertensive subjects (P < 0.001 for all) with adjusted odds ratio of 5.2 (95%CI 2.9-9.2) among the SDH subjects, 2.6 (95%CI 1.5-4.5) among the IDH subjects, and 2.2 (95%CI 1.2-4.5) among the ISH subjects. When the definition of HT was based on ambulatory blood pressure (mean daytime blood pressure > or =135/85 mm Hg, n = 798), odds ratios were 5.1 (95%CI 3.1-8.2), 5.6 (95%CI 3.2-9.8), and 3.3 (95%CI 1.7-6.3), respectively. In the fully adjusted logistic model, the risk of ambulatory HT was smaller for the ISH than the IDH (P = 0.049) or SDH (P = 0.053) individuals. CONCLUSIONS: The present results indicate that young-to-middle-age subjects with ISH have a smaller risk of developing ambulatory HT than either subjects with SDH or IDH. Whether antihypertensive treatment can be postponed for long periods of time in young subjects with mild elevations of clinic systolic BP and low global cardiovascular risk should be examined in further studies.

Regular physical activity prevents development of left ventricular hypertrophy in hypertension.

AIMS: The longitudinal relationship between aerobic exercise and left ventricular (LV) mass in hypertension is not well known. We did a prospective study to investigate the long-term effect of regular physical activity on development of LV hypertrophy (LVH) in a cohort of young subjects screened for Stage 1 hypertension. METHODS AND RESULTS: We assessed 454 subjects whose physical activity status was consistent during the follow-up. Echocardiographic LV mass was measured at entry, every 5 years, and/or at the time of hypertension development before starting treatment. LVH was defined as an LV mass >/=50 g/m(2.7) in men and >/=47 g/m(2.7) in women. During a median follow-up of 8.3 years, 32 subjects developed LVH (sedentary, 10.3%; active, 1.7%, P = 0.000). In a logistic regression, physically active groups combined (n = 173) were less likely to develop LVH than sedentary group with a crude OR = 0.15 (CI, 0.05-0.52). After controlling for sex, age, family history for hypertension, hypertension duration, body mass, blood pressure, baseline LV mass, lifestyle factors, and follow-up length, the OR was 0.24 (CI, 0.07-0.85). Blood pressure declined over time in physically active subjects (-5.1 +/- 17.0/-0.5 +/- 10.2 mmHg) and slightly increased in their sedentary peers (0.0 +/- 15.3/0.9 +/- 9.7 mmHg, adjusted P vs. active = 0.04/0.06). Inclusion of changes in blood pressure over time into the logistic model slightly decreased the strength of the association between physical activity status and LVH development (OR = 0.25, CI, 0.07-0.87). CONCLUSION: Regular physical activity prevents the development of LVH in young stage 1 hypertensive subjects. This effect is independent from the reduction in blood pressure caused by exercise.

Angiotensin II type 1 receptor gene polymorphism predicts development of hypertension and metabolic syndrome.

BACKGROUND: The aim of the study was to investigate the effect of polymorphism A1166C for AGTR1 and -1332G/A for AGTR2 on the incidence of sustained hypertension (HT) and metabolic syndrome in a cohort of young patients screened for stage 1 HT. METHODS: We assessed 420 white hypertensive subjects never treated for HT and followed up for 7.3 years in the HT and Ambulatory Recording Venetia Study (HARVEST). Incident physician-diagnosed HT, increase in ambulatory blood pressure (BP), and new onset metabolic syndrome were the outcome measures. RESULTS: For AGTR1, 37.2% of the subjects in the group with AA genotype, 47.5% in the group with AC genotype, and 66.7% in the group with CC genotype developed HT during follow-up (P = 0.001). Ambulatory systolic (P = 0.007) and diastolic (P < 0.001) BPs increased largely in the patients with CC genotype than in the rest of the group. New onset metabolic syndrome during follow-up (n = 30, P = 0.008), and the frequency of the metabolic syndrome at the end of follow-up (n = 65, P = 0.002) were also more common among the patients with CC and AC genotype. In a Cox analysis, subjects with CC genotype had an increased risk of developing HT (hazard ratio (HR) 1.6, 95% confidence interval (CI) 1.2-2.0, P = 0.000) and metabolic syndrome (HR 2.8, 1.5-5.2, P = 0.002) than AA subjects. No association was found between the AGTR2 polymorphism and any outcome measure. CONCLUSIONS: The AGTR1 A1166C polymorphism may be considered a genetic marker predisposing to an increase in BP and the development of the metabolic syndrome in subjects screened for stage 1 HT.

Validation of the Microlife BP W200-1 wrist device for blood pressure measurement.

OBJECTIVE: The objective of the study was to determine the accuracy of the BP W200-1 device for blood pressure measurement at the wrist developed by the Microlife Company. The BP W200-1 model features a 'Microlife Average Mode', which uses a 'weighted' average of a minimum of three consecutive blood pressure (BP) readings taken 15 s apart. METHOD: Device evaluation was carried out using the International Protocol of the European Society of Hypertension. Monitor performance was assessed in relation to patients' sex, age, wrist circumference, and systolic (SBP) and diastolic blood pressures (DBP). RESULTS: The BP W200-1 comfortably passed all three phases of the protocol for SBP and DBP. The device performed well in all ranges of SBP and DBP. Mean blood pressure differences for the BP W200-1 monitor were -1.2+/-4.5 mmHg for SBP and -0.2+/-3.1 mmHg for DBP. In multivariable analyses, the SBP and DBP discrepancies between device and observer were unrelated to age, sex, wrist circumference, and blood pressure level. CONCLUSION: These data show that the Microlife BP W200-1 wrist monitor satisfies the recommended European Society of Hypertension accuracy levels for SBP and DBP and therefore can be recommended for clinical use in the adult population. Its performance is uniform across subgroups of patients with different clinical characteristics.

Increase in carotid intima-media thickness in grade I hypertensive subjects: white-coat versus sustained hypertension.

We studied 74 never-treated grade I hypertensive subjects aged 18 to 45 years and 20 normotensive control subjects to define the rate of increase in carotid intima-media thickness (IMT) and the potential role played by the various risk factors. IMT was assessed as mean IMT and as maximum IMT in the right and left common carotid artery, carotid bulb, and internal carotid artery at baseline and at the 5-year follow-up. In grade I hypertensive subjects, both mean IMT and mean of maximum IMT were significantly higher compared with baseline values. Compared with normotensive subjects, both mean IMT and maximum IMT increased significantly (at least P<0.01) in each carotid artery segment. The increase in cumulative IMT was 3.4-fold for mean IMT and 3.2-fold for mean of maximum IMT. Levels of mean arterial pressure at 24-hour monitoring and total serum cholesterol were factors potentially linked to the increment in mean IMT and mean of maximum IMT. Age was also relevant for the increment in mean of maximum IMT, whereas body mass index played some role in the increment of mean IMT. During the follow-up, mean IMT and mean of maximum IMT increased to a greater degree in white-coat hypertensive subjects (n=35) and sustained hypertensive subjects (n=39) than in normotensive control subjects. No differences were found between white-coat hypertensive subjects and sustained hypertensive subjects for both mean IMT and maximum IMT. Levels of mean arterial pressure at 24-hour monitoring affected the increment in IMT in both white-coat hypertensive subjects and sustained hypertensive subjects. In conclusion, our findings indicate that carotid IMT is greater and grows faster in white-coat hypertensive subjects than in normotensive subjects without significant differences with sustained hypertensive patients.

RGS2 C1114G polymorphism and body weight gain in hypertensive patients.

RGS2 is a negative regulator of Galpha protein signaling and promotes adipocyte differentiation. Recently, we described a polymorphism at the C1114G locus with the G allele associated with hypertension in a cross-sectional study. The aim of the present study was to assess whether the RGS2 C1114G is predictive of overweight in young subjects with grade I hypertension. We genotyped at the RGS2 C1114G locus 406 (male, n = 294; female, n = 112) white hypertensive subjects (age, 33 +/- 9 years) never treated for hypertension and at low cardiovascular risk. Median follow-up was 7.85 years. At baseline, male patients carrying the RGS2 1114G allele had higher body mass index (BMI) than patients with CC genotype (26.1 +/- 0.3 vs 25.3 +/- 0.3 kg/m2, P < .05). The frequency of male patients with BMI > or = 25 was similar between the patients with G allele and those with CC genotype (55.1% vs 47.8%, P = not significant). No significant difference between the 2 groups was observed with regard to physical activity, blood pressure, and heart rate. At the end of follow-up, BMI was higher in male patients with G allele compared with patients with CC genotype (26.8 +/- 0.3 vs 25.8 +/- 0.2 kg/m2, P < .01); and the frequency of male patients with BMI >25 kg/m2 was greater in the former (69.0% vs 52.2%, P < .01). According to Cox regression, allele G was a significant predictor of developing overweight or obesity during follow-up. These epidemiologic relations were not significant in female patients. In young male patients with grade I hypertension, RGS2 1114G allele is associated with increased BMI and with greater risk of developing overweight or obesity. The RGS2 1114G allele may be considered a genetic marker that predicts an individual's predisposition to gaining weight.

Association between coffee consumption and risk of hypertension.

BACKGROUND: The longitudinal relationship between coffee use and hypertension is not well known. Aim. We did a prospective study to investigate if there is a temporal relationship between coffee consumption and development of sustained hypertension. METHOD: We assessed 1107 white subjects with elevated blood pressure who were followed up for 6.4 years. Coffee intake and other life-style factors were ascertained from regularly administered questionnaires. Incident physician-diagnosed hypertension was the outcome measure. RESULTS: During the follow-up, 561 subjects developed sustained hypertension, whereas 546 subjects did not meet the criteria for treatment. Coffee drinkers developed sustained hypertension more frequently than abstainers (53.1% versus 43.9%, P = 0.007). The incidence of hypertension did not differ between moderate and heavy coffee drinkers. Kaplan-Meier analysis confirmed that sustained hypertension was developed more frequently by coffee drinkers compared with nondrinkers (P<0.001). The adjusted relative risk of hypertension was greater in both categories of coffee drinking than in abstainers (hazard ratio, 95% confidence limit (CL) = 1.24, 1.06-1.44). The risk of hypertension associated with coffee drinking increased gradually with increasing level of alcohol use (adjusted P for interaction = 0.005). CONCLUSIONS: In subjects screened for stage 1 hypertension a nonlinear association was found between coffee consumption and development of sustained hypertension.

Validation of Heine Gamma G7 (G5) and XXL-LF aneroid devices for blood pressure measurement.

OBJECTIVE: To determine the accuracy of the Gamma G7 (and G5 model) and XXL-LF aneroid sphygmomanometers developed by the Heine Company. DESIGN: Device evaluations were performed using the new protocol of the European Society of Hypertension. Monitor performance was assessed in relation to participants' sex, age, arm circumference, and systolic and diastolic blood pressures. METHODS: The two sphygmomanometers were assessed in two different samples according to European Society of Hypertension requirements, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg, or more. RESULTS: Both sphygmomanometers passed all three phases of the protocol for systolic blood pressure and diastolic blood pressure. Mean blood pressure difference between Gamma G7 sphygmomanometer and observers was -0.4+/-3.3 mmHg for systolic blood pressure and -0.5+/-2.6 mmHg for diastolic blood pressure. Mean differences for the Gamma XXL-LF sphygmomanometer were -0.3+/-3.7 and -1.0+/-2.6 mmHg, respectively. In multivariable analyses, the SBP discrepancies between both aneroid sphygmomanometers and observers were unrelated to age, sex, arm circumference and systolic blood pressure. For diastolic blood pressure, a borderline relationship was found only for arm circumference (P=0.057) with the Gamma G7 device. CONCLUSIONS: These data show that the Heine Gamma G7 and Gamma XXL-LF aneroid sphygmomanometers satisfy the new recommended ESH accuracy levels for both SBP and DBP. Their performance is uniform across subgroups of participants with different clinical characteristics.

Effect of body weight loss on blood pressure after 6 years of follow-up in stage 1 hypertension.

BACKGROUND: Although it is known that weight reduction reduces blood pressure (BP) in overweight patients, the optimal body weight (BW) loss in terms of BP response is not yet established. We evaluated the relationship between decrease in BW and BP over time in 796 stage 1 hypertensives. METHODS: The 166 subjects who lost BW were divided into four groups according to percent of BW loss at the end of a 74-month follow-up (G1, >2% to 5%, G2, >5% to 9%, G3, >9% to 13%, and G4, >13%) and were compared to the 219 subjects without changes in BW (G0, -2% to +2%). The BW increased (>2%) in the remaining 411 subjects. RESULTS: Among subjects with BW loss there was a progressive decrease in final systolic BP associated with BW loss category up to G3 (P = .007), therefore at the end of follow-up G3 had systolic BP 6.2 mm Hg lower than G0 (P = .06). However, among G3 and G4 subjects systolic BP decrease was almost identical (-6.2 nu -5.7 mm Hg, respectively, P = not significant). Similar results were obtained for diastolic BP, which declined up to G3 (P = .013). G3 had final diastolic BP 3.6 mm Hg lower than G0 (P = .037), whereas change in diastolic BP in G4 subjects was similar to that in G0 (-0.9 nu +0.1 mm Hg, respectively, P = not significant). Similar results were obtained in the group with body mass index (BMI) >27 kg/m(2). CONCLUSIONS: Our results indicate that in stage 1 hypertensives followed for more than 6 years the dose-response relationship between BW loss and decrease in BP is not linear irrespective of initial BW. The BW loss >13% of initial weight did not elicit additional BP decrease.

Heart rate as a predictor of development of sustained hypertension in subjects screened for stage 1 hypertension: the HARVEST Study.

OBJECTIVE: Whether heart rate predicts the development of sustained hypertension in individuals with hypertension is not well known. We carried out a prospective study to investigate whether clinic and ambulatory heart rates assessed at baseline and changes in clinic heart rate during 6 months of follow-up were independent predictors of subsequent blood pressure (BP). METHODS: The study was conducted in a cohort of 1103 white, stage 1 hypertensive individuals from the HARVEST study, never treated for hypertension and followed-up for an average of 6.4 years. Data were adjusted for baseline BP, age, sex, body fatness, physical activity habits, parental hypertension, duration of hypertension, cigarette smoking, alcohol consumption, and change of body weight from baseline. RESULTS: Clinic heart rate and heart rate changes during the first 6 months of follow-up were independent predictors of subsequent systolic blood pressure (SBP) and diastolic blood pressure (DBP) regardless of initial BP and other confounders (all P < 0.01). A significant interaction was found between sex (male) and baseline resting heart rate on final SBP (P = 0.017) and DBP (P < 0.001). The ambulatory heart rate and the heart rate white-coat effect did not add prognostic information to that provided by the clinic heart rate. Patients whose heart rate was persistently elevated during the study had a doubled fully adjusted risk (95% confidence interval 1.4-2.9) of developing sustained hypertension in comparison with subjects with a normal heart rate. CONCLUSIONS: Baseline clinic heart rate and heart rate changes during the first few months of follow-up are independent predictors of the development of sustained hypertension in young persons screened for stage 1 hypertension.