Author(s):
Fuchs, Flávio D. ; Fuchs, Sandra C. ; Moreira, Leila B. ; Gus, Miguel ; Nóbrega, Antônio C. ; Poli-de-Figueiredo, Carlos E. ; Mion, Décio ; Bortolotto, Luiz ; Consolim-Colombo, Fernanda ; Nobre, Fernando ; Coelho, Eduardo B. ; Vilela-Martin, José F. ; Moreno Jr, Heitor ; Cesarino, Evandro J. ; Franco, Roberto [UNESP] ; Brandão, Andréa A. ; de Sousa, Marcos R. ; Pinho Ribeiro, Antônio L. ; Jardim, Paulo C. ; Neto, Abrahão A. ; Scala, Luiz C.N. ; Mota, Marco ; Chaves, Hilton ; Alves, João G. ; Sobral Filho, Dario C. ; e Silva, Ricardo P. ; Figueiredo Neto, José A. ; Irigoyen, Maria C. ; Castro, Iran ; Steffens, André A. ; Schlatter, Rosane ; de Mello, Renato B. ; Mosele, Francisca ; Ghizzoni, Flávia ; Berwanger, Otávio
Date: 2014
Persistent ID: http://hdl.handle.net/11449/72312
Origin: Oasisbr
Subject(s): amiloride; amlodipine; chlortalidone; dipeptidyl carboxypeptidase inhibitor; losartan; potassium sparing diuretic agent; propranolol; angiotensin 1 receptor antagonist; antihypertensive agent; diuretic agent; atherosclerosis; blood pressure; blood pressure measurement; disease severity; double blind procedure; electrocardiogram; ethics; follow up; heart arrhythmia; heart failure; heart infarction; heart left ventricle hypertrophy; human; hyperglycemia; hypertension; hypokalemia; lifestyle modification; medical research; microalbuminuria; outcome assessment; outpatient; randomized controlled trial; renal protection; stroke; sudden death; adult; aged; Brazil; clinical trial; comparative study; controlled clinical trial; controlled study; drug combination; drug effect; female; hospitalization; male; methodology; middle aged; multicenter study; pathophysiology; time; treatment outcome; Adult; Aged; Amiloride; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Blood Pressure; Chlorthalidone; Diuretics; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hypertension; Losartan; Male; Middle Aged; Research Design; Severity of Illness Index; Time Factors; Treatment Outcome
Description
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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. © 2011 Fuchs et al; licensee BioMed Central Ltd.
Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande do Sul, Porto Alegre
Hospital Universitário Antônio Pedro Universidade Federal Fluminense, Niterói
Hospital São Lucas Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre
Hospital das Clinicas Universidade de São Paulo, São Paulo
Instituto do Coração Universidade de São Paulo, São Paulo
Faculdade de Medicina de Ribeirão Preto Universidade de São Paulo, Ribeirão Preto
Faculdade de Medicina São José do Rio Preto São José do Rio Preto
Faculdade de Ciências Médicas Universidade de Campinas, Campinas
Faculdade de Ciências Farmacêuticas Universidade de São Paulo, Ribeirão Preto
Faculdade de Medicina de Botucatu Universidade Estadual de São Paulo, Botucatu
Universidade do Estado do Rio de Janeiro, Rio de Janeiro
Hospital das Clínicas Universidade Federal de Minas Gerais, Belo Horizonte
Hospital das Clínicas de Goiânia Universidade Federal de Goiás, Goiânia
Anis Rassi Hospital, Goiânia
Hospital Universitário Júlio Muller Universidade Federal de Mato Grosso, Cuiabá
Faculdade de Medicina Universidade de Ciências da Saúde Alagoas, Maceió
Faculdade de Medicina Universidade Federal de Pernambuco, Recife
Instituto de Medicina Integral Prof Fernando Figueira, Recife
Hospital Universitário Oswaldo Cruz/PROCAPE Universidade de Pernambuco, Recife
Hospital Universitário Valter Cantídio Universidade Federal do Ceará, Fortaleza
Hospital Universitário Universidade Federal Maranhão, São Luiz
Instituto de Cardiologia Fundação Universitária de Cardiologia, Porto Alegre
Faculdade de Medicina Universidade Federal de Pelotas, Pelotas
Hospital do Coração, São Paulo
Faculdade de Medicina de Botucatu Universidade Estadual de São Paulo, Botucatu
