Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial
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- 作者：Flávio D Fuchs (1)
Sandra C Fuchs (1)
Leila B Moreira (1)
Miguel Gus (1)
Ant?nio C Nóbrega (2)
Carlos E Poli-de-Figueiredo (3)
Décio Mion (4)
Luiz Bortoloto (5)
Fernanda Consolim-Colombo (5)
Fernando Nobre (6)
Eduardo Barbosa Coelho (6)
José F Vilela-Martin (7)
Heitor Moreno Jr (8)
Evandro José Cesarino (9)
Roberto Franco (10)
Andréa Araujo Brand?o (11)
Marcos R de Sousa (12)
Ant?nio Luiz Pinho Ribeiro (12)
Paulo Cesar Jardim (13)
Abrah?o Afiune Neto (14)
Luiz César N Scala (15)
Marco Mota (16)
Hilton Chaves (17)
Jo?o Guilherme Alves (18)
Dario C Sobral Filho (19)
Ricardo Pereira e Silva (20)
José A Figueiredo Neto (21)
Cláudia Maria Irigoyen (22)
Iran Castro (22)
Avelino André Steffens (23)
Rosane Schlatter (1)
Bandeira Renato de Mello (1)
Francisca Mosele (1)
Flávia Ghizzoni (1)
Otávio Berwanger (24) - 刊名：Trials
- 出版年：2011
- 出版时间：December 2011
- 年：2011
- 卷：12
- 期：1
- 全文大小：327KB
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26. Guerrero P, Fuchs FD, Moreira LM, Martins VM, Bertoluci C, Fuchs SC, Gus M: Blood pressure-lowering efficacy of amiloride versus enalapril as add-on drugs in patients with uncontrolled blood pressure receiving hydrochlorothiazide. / Clin Exp Hypertens 2008, 30:553-4. f="http://dx.doi.org/10.1080/10641960802441906">CrossRef - 作者单位：Flávio D Fuchs (1)
Sandra C Fuchs (1)
Leila B Moreira (1)
Miguel Gus (1)
Ant?nio C Nóbrega (2)
Carlos E Poli-de-Figueiredo (3)
Décio Mion (4)
Luiz Bortoloto (5)
Fernanda Consolim-Colombo (5)
Fernando Nobre (6)
Eduardo Barbosa Coelho (6)
José F Vilela-Martin (7)
Heitor Moreno Jr (8)
Evandro José Cesarino (9)
Roberto Franco (10)
Andréa Araujo Brand?o (11)
Marcos R de Sousa (12)
Ant?nio Luiz Pinho Ribeiro (12)
Paulo Cesar Jardim (13)
Abrah?o Afiune Neto (14)
Luiz César N Scala (15)
Marco Mota (16)
Hilton Chaves (17)
Jo?o Guilherme Alves (18)
Dario C Sobral Filho (19)
Ricardo Pereira e Silva (20)
José A Figueiredo Neto (21)
Cláudia Maria Irigoyen (22)
Iran Castro (22)
Avelino André Steffens (23)
Rosane Schlatter (1)
Bandeira Renato de Mello (1)
Francisca Mosele (1)
Flávia Ghizzoni (1)
Otávio Berwanger (24)
1. Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
2. Hospital Universitário Ant?nio Pedro, Universidade Federal Fluminense, Niterói, Brazil
3. Hospital S?o Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil
4. Hospital das Clinicas, Universidade de S?o Paulo, S?o Paulo, Brazil
5. Instituto do Cora??o, Universidade de S?o Paulo, S?o Paulo, Brazil
6. Faculdade de Medicina de Ribeir?o Preto, Universidade de S?o Paulo, Ribeir?o Preto, Brazil
7. Faculdade de Medicina S?o José do Rio Preto, S?o José do Rio Preto, Brazil
8. Faculdade de Ciências Médicas, Universidade de Campinas, Campinas, Brazil
9. Faculdade de Ciências Farmacêuticas, Universidade de S?o Paulo, Ribeir?o Preto, Brazil
10. Faculdade de Medicina de Botucatu, Universidade de S?o 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 Goiania, Universidade Federal de Goiás, Goiania, Brazil
14. Anis Rassi Hospital, Goiania, 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 Maranh?o, S?o Luiz, Brazil
22. Instituto de Cardiologia, Funda??o Universitária de Cardiologia, Porto Alegre, Brazil
23. Faculdade de Medicina, Universidade Federal de Pelotas, Pelotas, Brazil
24. Hospital do Cora??o, S?o Paulo, Brazil
文摘
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.