Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

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Abstract

Background

Blood pressure (BP) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage.

Methods

This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution.

Discussion

The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe in a population-based perspective, it could be the basis for an innovative public health program to prevent hypertension in Brazil.

Trial Registration

Clinical Trials NCT00970931.

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Most cited references 18

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Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial.

Lawrence Appel, Catherine Champagne, David W Harsha … (2003)

Weight loss, sodium reduction, increased physical activity, and limited alcohol intake are established recommendations that reduce blood pressure (BP). The Dietary Approaches to Stop Hypertension (DASH) diet also lowers BP. To date, no trial has evaluated the effects of simultaneously implementing these lifestyle recommendations. To determine the effect on BP of 2 multicomponent, behavioral interventions. Randomized trial with enrollment at 4 clinical centers (January 2000-June 2001) among 810 adults (mean [SD] age, 50 [8.9] years; 62% women; 34% African American) with above-optimal BP, including stage 1 hypertension (120-159 mm Hg systolic and 80-95 mm Hg diastolic), and who were not taking antihypertensive medications. Participants were randomized to one of 3 intervention groups: (1) "established," a behavioral intervention that implemented established recommendations (n = 268); (2) "established plus DASH,"which also implemented the DASH diet (n = 269); and (3) an "advice only" comparison group (n = 273). Blood pressure measurement and hypertension status at 6 months. Both behavioral interventions significantly reduced weight, improved fitness, and lowered sodium intake. The established plus DASH intervention also increased fruit, vegetable, and dairy intake. Across the groups, gradients in BP and hypertensive status were evident. After subtracting change in advice only, the mean net reduction in systolic BP was 3.7 mm Hg (P<.001) in the established group and 4.3 mm Hg (P<.001) in the established plus DASH group; the systolic BP difference between the established and established plus DASH groups was 0.6 mm Hg (P =.43). Compared with the baseline hypertension prevalence of 38%, the prevalence at 6 months was 26% in the advice only group, 17% in the established group (P =.01 compared with the advice only group), and 12% in the established plus DASH group (P<.001 compared with the advice only group; P =.12 compared with the established group). The prevalence of optimal BP (<120 mm Hg systolic and <80 mm Hg diastolic) was 19% in the advice only group, 30% in the established group (P =.005 compared with the advice only group), and 35% in the established plus DASH group (P<.001 compared with the advice only group; P =.24 compared with the established group). Individuals with above-optimal BP, including stage 1 hypertension, can make multiple lifestyle changes that lower BP and reduce their cardiovascular disease risk.

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Effects of weight loss and sodium reduction intervention on blood pressure and hypertension incidence in overweight people with high-normal blood pressure. The Trials of Hypertension Prevention, phase II. The Trials of Hypertension Prevention Collaborative Research Group.

JA Cutler (1997)

To provide a firmer basis for preventing high blood pressure (BP), we tested interventions to promote weight loss, dietary sodium reduction, and their combination for lowering diastolic BP, systolic BP, and the incidence of hypertension during a 3- to 4-year period. We conducted a randomized, 2 x 2 factorial, clinical trial, with BP levels measured by blinded observers. Nine academic medical centers recruited 2382 men and women (age range, 30-54 years) not taking antihypertensive drugs, with a diastolic BP of 83 to 89 mm Hg, a systolic BP lower than 140 mm Hg, and a body mass index (the weight in kilograms divided by the square of the height in meters) representing 110% to 165% of desirable body weight. Counseling aimed at helping participants achieve their desirable weight or a 4.5-kg or more weight reduction (in the weight loss and combined groups) and/or sodium intake of 80 mmol/d (in the sodium reduction and combined groups) was provided. From baseline, participants' weight decreased by 4.3 to 4.5 kg at 6 months and by approximately 2 kg at 36 months in the weight loss and combined groups compared with weight changes in the usual care group (all groups, P or = 140 mm Hg systolic or > or = 90 mm Hg diastolic or the use of antihypertensive drugs) was significantly less in each active intervention group than the usual care group (average relative risks, 0.78-0.82). In overweight adults with high-normal BP, weight loss and reduction in sodium intake, individually and in combination, were effective in lowering systolic and diastolic BP, especially in the short-term (6 months). Although the effects on average BP declined over time, reductions in hypertension incidence were achieved.

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Prehypertension and cardiovascular disease risk in the Women's Health Initiative.

Russell L. Margolis, Nanette K. Wenger, … (2007)

Prehypertension is common and is associated with increased vascular mortality. The extent to which it increases risk of nonfatal myocardial infarction, stroke, and congestive heart failure is less clear. We determined the prevalence of prehypertension, its association with other coronary risk factors, and the risk for incident cardiovascular disease events in 60,785 postmenopausal women during 7.7 years of follow-up using Cox regression models that included covariates as time-dependent variables. Prehypertension was present at baseline in 39.5%, 32.1%, 42.6%, 38.7%, and 40.3% of white, black, Hispanic, American Indian, and Asian women, respectively (P<0.0001 across ethnic groups). Age, body mass index, and prevalence of diabetes mellitus and hypercholesterolemia increased across blood pressure categories, whereas smoking decreased (all P<0.0001). Compared with normotensive women (referent), adjusted hazard ratios for women with prehypertension were 1.58 (95% confidence interval [CI], 1.12 to 2.21) for cardiovascular death, 1.76 (95% CI, 1.40 to 2.22) for myocardial infarction, 1.93 (95% CI, 1.49 to 2.50) for stroke, 1.36 (95% CI, 1.05 to 1.77) for hospitalized heart failure, and 1.66 (95% CI, 1.44 to 1.92) for any cardiovascular event. Hazard ratios for the composite outcome with prehypertension did not differ between ethnic groups (P=0.71 for interaction), although the numbers of events among Hispanic and Asian women were small. Prehypertension is common and was associated with increased risk of myocardial infarction, stroke, heart failure, and cardiovascular death in white and nonwhite postmenopausal women. Risk factor clustering was conspicuous, emphasizing the need for trials evaluating the efficacy of global cardiovascular risk reduction through primordial prevention.

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Author and article information

Journal

Journal ID (nlm-ta): Trials

Title: Trials

Publisher: BioMed Central

ISSN (Electronic): 1745-6215

Publication date Collection: 2011

Publication date (Electronic): 5 March 2011

Volume: 12

Page: 65

Affiliations

[1 ]Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil

[2 ]Hospital Universitário Antônio Pedro, Universidade Federal Fluminense, Niterói, Brazil

[3 ]Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil

[4 ]Hospital das Clinicas, Universidade de São Paulo, São Paulo, Brazil

[5 ]Instituto do Coração, Universidade de São Paulo, São Paulo, Brazil

[6 ]Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo, Ribeirão Preto, Brazil

[7 ]Faculdade de Medicina São José do Rio Preto, São José do Rio Preto, Brazil

[8 ]Faculdade de Ciências Médicas, Universidade de Campinas, Campinas, Brazil

[9 ]Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, Ribeirão Preto, Brazil

[10 ]Faculdade de Medicina de Botucatu, Universidade Estadual de São Paulo, Botucatu, Brazil

[11 ]Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

[12 ]Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil

[13 ]Hospital das Clínicas de Goiânia, Universidade Federal de Goiás, Goiânia, Brazil

[14 ]Anis Rassi Hospital, Goiânia, Brazil

[15 ]Hospital Universitário Júlio Muller, Universidade Federal de Mato Grosso, Cuiabá, Brazil

[16 ]Faculdade de Medicina, Universidade de Ciências da Saúde Alagoas, Maceió, Brazil

[17 ]Faculdade de Medicina, Universidade Federal de Pernambuco, Recife, Brazil

[18 ]Instituto de Medicina Integral Prof Fernando Figueira, Recife, Brazil

[19 ]Hospital Universitário Oswaldo Cruz/PROCAPE, Universidade de Pernambuco, Recife, Brazil

[20 ]Hospital Universitário Valter Cantídio, Universidade Federal do Ceará, Fortaleza, Brazil

[21 ]Hospital Universitário, Universidade Federal Maranhão, São Luiz, Brazil

[22 ]Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, Brazil

[23 ]Faculdade de Medicina, Universidade Federal de Pelotas, Pelotas, Brazil

[24 ]Hospital do Coração, São Paulo, Brazil

Article

Publisher ID: 1745-6215-12-65

DOI: 10.1186/1745-6215-12-65

PMC ID: 3059277

PubMed ID: 21375762

SO-VID: 8a2bd151-2edf-49b1-a224-705c726355e9

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

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Abstract

Background

Methods

Discussion

Trial Registration

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Tobacco Prevention & Cessation

Most cited references 18

Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial.

Effects of weight loss and sodium reduction intervention on blood pressure and hypertension incidence in overweight people with high-normal blood pressure. The Trials of Hypertension Prevention, phase II. The Trials of Hypertension Prevention Collaborative Research Group.

Prehypertension and cardiovascular disease risk in the Women's Health Initiative.

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