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

dc.contributorUniversidade Estadual Paulista (UNESP)
dc.creatorFuchs, Flávio D.
dc.creatorFuchs, Sandra C.
dc.creatorMoreira, Leila B.
dc.creatorGus, Miguel
dc.creatorNóbrega, Antônio C.
dc.creatorPoli-de-Figueiredo, Carlos E.
dc.creatorMion, Décio
dc.creatorBortolotto, Luiz
dc.creatorConsolim-Colombo, Fernanda
dc.creatorNobre, Fernando
dc.creatorCoelho, Eduardo B.
dc.creatorVilela-Martin, José F.
dc.creatorMoreno Jr, Heitor
dc.creatorCesarino, Evandro J.
dc.creatorFranco, Roberto
dc.creatorBrandão, Andréa A.
dc.creatorde Sousa, Marcos R.
dc.creatorPinho Ribeiro, Antônio L.
dc.creatorJardim, Paulo C.
dc.creatorNeto, Abrahão A.
dc.creatorScala, Luiz C.N.
dc.creatorMota, Marco
dc.creatorChaves, Hilton
dc.creatorAlves, João G.
dc.creatorSobral Filho, Dario C.
dc.creatore Silva, Ricardo P.
dc.creatorFigueiredo Neto, José A.
dc.creatorIrigoyen, Maria C.
dc.creatorCastro, Iran
dc.creatorSteffens, André A.
dc.creatorSchlatter, Rosane
dc.creatorde Mello, Renato B.
dc.creatorMosele, Francisca
dc.creatorGhizzoni, Flávia
dc.creatorBerwanger, Otávio
dc.date2014-05-27T11:25:28Z
dc.date2016-10-25T18:33:35Z
dc.date2014-05-27T11:25:28Z
dc.date2016-10-25T18:33:35Z
dc.date2011-02-24
dc.date.accessioned2017-04-06T01:49:27Z
dc.date.available2017-04-06T01:49:27Z
dc.identifierTrials, v. 12.
dc.identifier1745-6215
dc.identifierhttp://hdl.handle.net/11449/72312
dc.identifierhttp://acervodigital.unesp.br/handle/11449/72312
dc.identifier10.1186/1745-6215-12-53
dc.identifier2-s2.0-79951956492.pdf
dc.identifier2-s2.0-79951956492
dc.identifierhttp://dx.doi.org/10.1186/1745-6215-12-53
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/893194
dc.descriptionBackground: 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.
dc.languageeng
dc.relationTrials
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectamiloride
dc.subjectamlodipine
dc.subjectchlortalidone
dc.subjectdipeptidyl carboxypeptidase inhibitor
dc.subjectlosartan
dc.subjectpotassium sparing diuretic agent
dc.subjectpropranolol
dc.subjectangiotensin 1 receptor antagonist
dc.subjectantihypertensive agent
dc.subjectdiuretic agent
dc.subjectatherosclerosis
dc.subjectblood pressure
dc.subjectblood pressure measurement
dc.subjectdisease severity
dc.subjectdouble blind procedure
dc.subjectelectrocardiogram
dc.subjectethics
dc.subjectfollow up
dc.subjectheart arrhythmia
dc.subjectheart failure
dc.subjectheart infarction
dc.subjectheart left ventricle hypertrophy
dc.subjecthuman
dc.subjecthyperglycemia
dc.subjecthypertension
dc.subjecthypokalemia
dc.subjectlifestyle modification
dc.subjectmedical research
dc.subjectmicroalbuminuria
dc.subjectoutcome assessment
dc.subjectoutpatient
dc.subjectrandomized controlled trial
dc.subjectrenal protection
dc.subjectstroke
dc.subjectsudden death
dc.subjectadult
dc.subjectaged
dc.subjectBrazil
dc.subjectclinical trial
dc.subjectcomparative study
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdrug combination
dc.subjectdrug effect
dc.subjectfemale
dc.subjecthospitalization
dc.subjectmale
dc.subjectmethodology
dc.subjectmiddle aged
dc.subjectmulticenter study
dc.subjectpathophysiology
dc.subjecttime
dc.subjecttreatment outcome
dc.subjectAdult
dc.subjectAged
dc.subjectAmiloride
dc.subjectAngiotensin II Type 1 Receptor Blockers
dc.subjectAntihypertensive Agents
dc.subjectBlood Pressure
dc.subjectChlorthalidone
dc.subjectDiuretics
dc.subjectDouble-Blind Method
dc.subjectDrug Therapy, Combination
dc.subjectFemale
dc.subjectHumans
dc.subjectHypertension
dc.subjectLosartan
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectResearch Design
dc.subjectSeverity of Illness Index
dc.subjectTime Factors
dc.subjectTreatment Outcome
dc.titleA 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
dc.typeOtro


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