A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial
Autor(a) principal: | |
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Data de Publicação: | 2011 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1186/1745-6215-12-53 http://hdl.handle.net/11449/72312 |
Resumo: | 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. |
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A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trialamilorideamlodipinechlortalidonedipeptidyl carboxypeptidase inhibitorlosartanpotassium sparing diuretic agentpropranololangiotensin 1 receptor antagonistantihypertensive agentdiuretic agentatherosclerosisblood pressureblood pressure measurementdisease severitydouble blind procedureelectrocardiogramethicsfollow upheart arrhythmiaheart failureheart infarctionheart left ventricle hypertrophyhumanhyperglycemiahypertensionhypokalemialifestyle modificationmedical researchmicroalbuminuriaoutcome assessmentoutpatientrandomized controlled trialrenal protectionstrokesudden deathadultagedBrazilclinical trialcomparative studycontrolled clinical trialcontrolled studydrug combinationdrug effectfemalehospitalizationmalemethodologymiddle agedmulticenter studypathophysiologytimetreatment outcomeAdultAgedAmilorideAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsBlood PressureChlorthalidoneDiureticsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHypertensionLosartanMaleMiddle AgedResearch DesignSeverity of Illness IndexTime FactorsTreatment OutcomeBackground: 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 AlegreHospital Universitário Antônio Pedro Universidade Federal Fluminense, NiteróiHospital São Lucas Pontifícia Universidade Católica do Rio Grande do Sul, Porto AlegreHospital das Clinicas Universidade de São Paulo, São PauloInstituto do Coração Universidade de São Paulo, São PauloFaculdade de Medicina de Ribeirão Preto Universidade de São Paulo, Ribeirão PretoFaculdade de Medicina São José do Rio Preto São José do Rio PretoFaculdade de Ciências Médicas Universidade de Campinas, CampinasFaculdade de Ciências Farmacêuticas Universidade de São Paulo, Ribeirão PretoFaculdade de Medicina de Botucatu Universidade Estadual de São Paulo, BotucatuUniversidade do Estado do Rio de Janeiro, Rio de JaneiroHospital das Clínicas Universidade Federal de Minas Gerais, Belo HorizonteHospital das Clínicas de Goiânia Universidade Federal de Goiás, GoiâniaAnis Rassi Hospital, GoiâniaHospital Universitário Júlio Muller Universidade Federal de Mato Grosso, CuiabáFaculdade de Medicina Universidade de Ciências da Saúde Alagoas, MaceióFaculdade de Medicina Universidade Federal de Pernambuco, RecifeInstituto de Medicina Integral Prof Fernando Figueira, RecifeHospital Universitário Oswaldo Cruz/PROCAPE Universidade de Pernambuco, RecifeHospital Universitário Valter Cantídio Universidade Federal do Ceará, FortalezaHospital Universitário Universidade Federal Maranhão, São LuizInstituto de Cardiologia Fundação Universitária de Cardiologia, Porto AlegreFaculdade de Medicina Universidade Federal de Pelotas, PelotasHospital do Coração, São PauloFaculdade de Medicina de Botucatu Universidade Estadual de São Paulo, BotucatuUniversidade Federal do Rio Grande do Sul (UFRGS)Universidade Federal Fluminense (UFF)Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)Universidade de São Paulo (USP)São José do Rio PretoUniversidade Estadual de Campinas (UNICAMP)Universidade Estadual Paulista (Unesp)Universidade do Estado do Rio de Janeiro (UERJ)Universidade Federal de Minas Gerais (UFMG)Universidade Federal de Goiás (UFG)Anis Rassi HospitalUniversidade Federal de Mato GrossoUniversidade de Ciências da Saúde AlagoasUniversidade Federal de Pernambuco (UFPE)Instituto de Medicina Integral Prof Fernando FigueiraUniversidade de PernambucoUniversidade Federal do Ceará (UFC)Universidade Federal MaranhãoFundação Universitária de CardiologiaUniversidade Federal de Pelotas (UFPEL)Hospital do CoraçãoFuchs, Flávio D.Fuchs, Sandra C.Moreira, Leila B.Gus, MiguelNóbrega, Antônio C.Poli-de-Figueiredo, Carlos E.Mion, DécioBortolotto, LuizConsolim-Colombo, FernandaNobre, FernandoCoelho, Eduardo B.Vilela-Martin, José F.Moreno Jr, HeitorCesarino, 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, MarcoChaves, HiltonAlves, João G.Sobral Filho, Dario C.e Silva, Ricardo P.Figueiredo Neto, José A.Irigoyen, Maria C.Castro, IranSteffens, André A.Schlatter, Rosanede Mello, Renato B.Mosele, FranciscaGhizzoni, FláviaBerwanger, Otávio2014-05-27T11:25:28Z2014-05-27T11:25:28Z2011-02-24info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://dx.doi.org/10.1186/1745-6215-12-53Trials, v. 12.1745-6215http://hdl.handle.net/11449/7231210.1186/1745-6215-12-532-s2.0-799519564922-s2.0-79951956492.pdfScopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengTrials2.0671,291info:eu-repo/semantics/openAccess2024-01-21T06:19:41Zoai:repositorio.unesp.br:11449/72312Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T23:32:38.301722Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial |
title |
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial |
spellingShingle |
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial Fuchs, Flávio D. 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 |
title_short |
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial |
title_full |
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial |
title_fullStr |
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial |
title_full_unstemmed |
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial |
title_sort |
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial |
author |
Fuchs, Flávio D. |
author_facet |
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 |
author_role |
author |
author2 |
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 |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
dc.contributor.none.fl_str_mv |
Universidade Federal do Rio Grande do Sul (UFRGS) Universidade Federal Fluminense (UFF) Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS) Universidade de São Paulo (USP) São José do Rio Preto Universidade Estadual de Campinas (UNICAMP) Universidade Estadual Paulista (Unesp) Universidade do Estado do Rio de Janeiro (UERJ) Universidade Federal de Minas Gerais (UFMG) Universidade Federal de Goiás (UFG) Anis Rassi Hospital Universidade Federal de Mato Grosso Universidade de Ciências da Saúde Alagoas Universidade Federal de Pernambuco (UFPE) Instituto de Medicina Integral Prof Fernando Figueira Universidade de Pernambuco Universidade Federal do Ceará (UFC) Universidade Federal Maranhão Fundação Universitária de Cardiologia Universidade Federal de Pelotas (UFPEL) Hospital do Coração |
dc.contributor.author.fl_str_mv |
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 |
dc.subject.por.fl_str_mv |
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 |
topic |
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 |
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. |
publishDate |
2011 |
dc.date.none.fl_str_mv |
2011-02-24 2014-05-27T11:25:28Z 2014-05-27T11:25:28Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1186/1745-6215-12-53 Trials, v. 12. 1745-6215 http://hdl.handle.net/11449/72312 10.1186/1745-6215-12-53 2-s2.0-79951956492 2-s2.0-79951956492.pdf |
url |
http://dx.doi.org/10.1186/1745-6215-12-53 http://hdl.handle.net/11449/72312 |
identifier_str_mv |
Trials, v. 12. 1745-6215 10.1186/1745-6215-12-53 2-s2.0-79951956492 2-s2.0-79951956492.pdf |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Trials 2.067 1,291 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
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Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
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Universidade Estadual Paulista (UNESP) |
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UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
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Repositório Institucional da UNESP |
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Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
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