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

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

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Título Prevention of hypertension in patients with pre-hypertension : protocol for the PREVER-prevention trial
Autor Fuchs, Flávio Danni
Fuchs, Sandra Cristina Pereira Costa
Moreira, Leila Beltrami
Gus, Miguel
Nobrega, Antonio Claudio Lucas da
Figueiredo, Carlos Eduardo Poli de
Mion Junior, Décio
Bortolotto, Luiz Aparecido
Colombo, Fernanda Marciano Consolim
Nobre, Fernando
Coelho, Eduardo Barbosa
Martin, Jose Fernando Vilela
Moreno Junior, Heitor
Cesarino, Evandro José
Franco, Roberto Jorge da Silva
Brandão, Andréa Araujo
Sousa, Marcos Roberto de
Ribeiro, Antônio Luiz Pinho
Jardim, Paulo Cesar B. Veiga
Afiune Neto, Abrahão
Scala, Luiz César Nazário
Gomes, Marco Antônio Mota
Chaves, Hilton
Alves, João Guilherme Bezerra
Sobral Filho, Dário Celestino
Silva, Ricardo Pereira e
Figueiredo Neto, José Albuquerque de
Irigoyen, Maria Claudia Costa
Castro, Iran
Steffens, André Avelino
Schlatter, Rosane Paixão
Mello, Renato Bandeira de
Mosele, Francisca
Ghizzoni, Flávia
Berwanger, Otávio
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 populationbased 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 populationbased perspective, it could be the basis for an innovative public health program to prevent hypertension in Brazil.
Contido em Trials (Online). London. Vol. 12 (2011), 7 p.
Assunto Hipertensão
Pré-hipertensão
Prevenção e controle
Origem Estrangeiro
Tipo Artigo de periódico
URI http://hdl.handle.net/10183/30374
Arquivos Descrição Formato
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