Abstract
Background
Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted.
Methods/design
This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, 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 subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution.
Discussion
The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil.
Clinical trials registration number
ClinicalTrials.gov: NCT00971165
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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 Faculdade de Medicina São José do Rio Preto, São José do Rio Preto, Brazil (GRID:grid.419029.7) (ISNI:0000000406155265)
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)