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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Details
1 Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (GRID:grid.8532.c) (ISNI:0000000122007498)
2 Universidade Federal Fluminense, Hospital Universitário Antônio Pedro, Niterói, Brazil (GRID:grid.411173.1) (ISNI:0000000121846919)
3 Pontifícia Universidade Católica do Rio Grande do Sul, Hospital São Lucas, Porto Alegre, Brazil (GRID:grid.412519.a) (ISNI:0000000121669094)
4 Universidade de São Paulo, Hospital das Clinicas, São Paulo, Brazil (GRID:grid.11899.38) (ISNI:0000000419370722)
5 Universidade de São Paulo, Instituto do Coração, São Paulo, Brazil (GRID:grid.11899.38) (ISNI:0000000419370722)
6 Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, Brazil (GRID:grid.11899.38) (ISNI:0000000419370722)
7 São José do Rio Preto, Faculdade de Medicina São José do Rio Preto, Brazil (GRID:grid.419029.7) (ISNI:0000 0004 0615 5265)
8 Universidade de Campinas, Faculdade de Ciências Médicas, Campinas, Brazil (GRID:grid.411087.b) (ISNI:0000 0001 0723 2494)
9 Universidade de São Paulo, Faculdade de Ciências Farmacêuticas, Ribeirão Preto, Brazil (GRID:grid.11899.38) (ISNI:0000000419370722)
10 Universidade Estadual de São Paulo, Faculdade de Medicina de Botucatu, Botucatu, Brazil (GRID:grid.410543.7) (ISNI:000000012188478X)
11 Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil (GRID:grid.412211.5)
12 Universidade Federal de Minas Gerais, Hospital das Clínicas, Belo Horizonte, Brazil (GRID:grid.8430.f) (ISNI:0000000121814888)
13 Universidade Federal de Goiás, Hospital das Clínicas de Goiânia, Goiânia, Brazil (GRID:grid.411195.9) (ISNI:0000000121925801)
14 Anis Rassi Hospital, Goiânia, Brazil (GRID:grid.411195.9)
15 Universidade Federal de Mato Grosso, Hospital Universitário Júlio Muller, Cuiabá, Brazil (GRID:grid.411206.0) (ISNI:0000000123224953)
16 Universidade de Ciências da Saúde Alagoas, Faculdade de Medicina, Maceió, Brazil (GRID:grid.411206.0)
17 Universidade Federal de Pernambuco, Faculdade de Medicina, Recife, Brazil (GRID:grid.411227.3) (ISNI:0000000106707996)
18 Instituto de Medicina Integral Prof Fernando Figueira, Recife, Brazil (GRID:grid.419095.0) (ISNI:0000000404176556)
19 Universidade de Pernambuco, Hospital Universitário Oswaldo Cruz/PROCAPE, Recife, Brazil (GRID:grid.26141.30) (ISNI:0000000090115442)
20 Universidade Federal do Ceará, Hospital Universitário Valter Cantídio, Fortaleza, Brazil (GRID:grid.8395.7) (ISNI:0000000121600329)
21 Universidade Federal Maranhão, Hospital Universitário, São Luiz, Brazil (GRID:grid.411204.2) (ISNI:0000000121657632)
22 Fundação Universitária de Cardiologia, Instituto de Cardiologia, Porto Alegre, Brazil (GRID:grid.419062.8) (ISNI:0000000403975284)
23 Universidade Federal de Pelotas, Faculdade de Medicina, Pelotas, Brazil (GRID:grid.411221.5) (ISNI:0000000121346519)
24 Hospital do Coração, São Paulo, Brazil (GRID:grid.477370.0) (ISNI:000000040454243X)