Diuretics and Angiotensin-Receptor Blocker Agents in Patients With Stage I Hypertension - Full Text View

Purpose

High blood pressure is the major risk factor for Cardiovascular disease (CVD). The prevalence of hypertension in Brazil was established in population-based studies conducted in different cities and States, varying from 22.3 to 44% of adults.

The benefit of drug treatment of hypertension to prevent major cardiovascular events was consistently demonstrated in a large series of clinical trials controlled by placebo.

Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride.

A study comparing diuretic with an ARB agent is therefore recommendable in Brazil, in order to support the decisions of the Health Secretary in regard to blood pressure agents supply for the Brazilian population. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.

Condition	Intervention	Phase
Hypertension Cardiovascular Disease	Drug: losartan Drug: Chlorthalidone plus amiloride	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Comparison Between Diuretics and Angiotensin-receptor Blocker Agents in Patients With Stage I Hypertension: PREVER-treatment Study

Resource links provided by NLM:

Drug Information available for: Chlorthalidone Amiloride Amiloride hydrochloride Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

Blood pressure variation and proportion of use of add-on drugs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. [ Time Frame: 18 monyhs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

fatal or major cardiovascular events: myocardial infarction, stroke, coronary interventions, heart failure, duplication of creatinine [ Time Frame: 18 months ] [ Designated as safety issue: No ]


Enrollment:	655
Study Start Date:	July 2010
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Chlorthalidone plus amiloride Oral Chlorthalidone plus amiloride up to 25 e 5 mg daily for 18 months	Drug: Chlorthalidone plus amiloride Oral Chlorthalidone plus amiloride up to 25 e 5 mg daily, once a day for 18 months Other Name: diuretics
Experimental: losartan Oral losartan up to 100 mg daily, once a day, for 18 month	Drug: losartan Oral losartan up to 100 mg daily fo 18 months

Show Detailed Description

Eligibility


Ages Eligible for Study:	40 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients older than 40 years of age with stage I hypertension

Exclusion Criteria:

low life expectancy
other indications for the use of diuretics, such as cardiovascular disease
intolerance to the study drugs
pregnancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971165

Locations


Brazil
Hospital de Clínicas de Porto Alegre, UFRGS
Porto Alegre, RS, Brazil, 90035 903
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Financiadora de Estudos e Projetos

Investigators


Study Chair:	Flávio D Fuchs, MD, PhD	Hospital de Clínicas de Porto Alegre

More Information

Publications:

Fuchs FD, Fuchs SC, Moreira LB, Gus M, Nóbrega AC, Poli-de-Figueiredo CE, Mion D, Bortolotto L, Consolim-Colombo F, Nobre F, Coelho EB, Vilela-Martin JF, Moreno H Jr, Cesarino EJ, Franco R, Brandão AA, de Sousa MR, Ribeiro AL, Jardim PC, Afiune Neto A, Scala LC, Mota M, Chaves H, Alves JG, Sobral Filho DC, Pereira e Silva R, Figueiredo Neto JA, Irigoyen MC, Castro I, Steffens AA, Schlatter R, de Mello RB, Mosele F, Ghizzoni F, Berwanger O. 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. Trials. 2011 Feb 24;12:53. doi: 10.1186/1745-6215-12-53.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fuchs FD, Scala LC, Vilela-Martin JF, de Mello RB, Mosele F, Whelton PK, Poli-de-Figueiredo CE, de Alencastro PR, E Silva RP, Gus M, Bortolotto LA, Schlatter R, Cesarino EJ, Castro I, Neto JA, Chaves H, Steffens AA, Alves JG, Brandão AA, de Sousa MR, Jardim PC, Moreira LB, Franco RS, Gomes MM, Neto AA, Fuchs FC, Filho DC, Nóbrega AC, Nobre F, Berwanger O, Fuchs SC. Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension: results from the PREVER-treatment randomized trial. J Hypertens. 2016 Apr;34(4):798-806. doi: 10.1097/HJH.0000000000000837.


Responsible Party:	Flávio Danni Fuchs, Dr., Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00971165 History of Changes
Other Study ID Numbers:	GPPG08621-2
Study First Received:	September 2, 2009
Last Updated:	February 11, 2015
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:


Hypertension Chlorthalidone Amiloride Losartan treatment

Additional relevant MeSH terms:


Hypertension Cardiovascular Diseases Vascular Diseases Losartan Chlorthalidone Angiotensin Receptor Antagonists Diuretics Amiloride Anti-Arrhythmia Agents Antihypertensive Agents	Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs Acid Sensing Ion Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Epithelial Sodium Channel Blockers Diuretics, Potassium Sparing Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016

Diuretics and Angiotensin-Receptor Blocker Agents in Patients With Stage I Hypertension (PREVER)