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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
FINEP
Information provided by (Responsible Party):
Flávio Danni Fuchs, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00971165
First received: September 2, 2009
Last updated: December 2, 2013
Last verified: December 2013
  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:


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 ]

Estimated Enrollment: 866
Study Start Date: July 2010
Estimated Study Completion Date: September 2014
Estimated 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
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
Porto Alegre, RS, Brazil, 90035-903
Hospital de Clínicas de Porto Alegre, UFRGS
Porto Alegre, RS, Brazil, 90035 903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
FINEP
Investigators
Study Chair: Flávio D Fuchs, MD, PhD Hospital de Clínicas de Porto Alegre
  More Information

Publications:
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: December 2, 2013
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:
Cardiovascular Diseases
Hypertension
Vascular Diseases
Amiloride
Angiotensin Receptor Antagonists
Chlorthalidone
Diuretics
Losartan
Acid Sensing Ion Channel Blockers
Angiotensin II Type 1 Receptor Blockers
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Diuretics, Potassium Sparing
Epithelial Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014