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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971165
First Posted: September 3, 2009
Last Update Posted: February 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Financiadora de Estudos e Projetos
Information provided by (Responsible Party):
Flávio Danni Fuchs, Hospital de Clinicas de Porto Alegre
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Flávio Danni Fuchs, Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Blood pressure variation and proportion of use of add-on drugs [ Time Frame: 18 months ]
  • Adverse events [ Time Frame: 18 months ]
  • Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. [ Time Frame: 18 monyhs ]

Secondary Outcome Measures:
  • fatal or major cardiovascular events: myocardial infarction, stroke, coronary interventions, heart failure, duplication of creatinine [ Time Frame: 18 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: September 2, 2009
First Posted: September 3, 2009
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Flávio Danni Fuchs, 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
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing