Diuretics and Angiotensin-Receptor Blocker Agents in Patients With Stage I Hypertension (PREVER)
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.
|Hypertension Cardiovascular Disease||Drug: losartan Drug: Chlorthalidone plus amiloride||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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|
- 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 ]
- fatal or major cardiovascular events: myocardial infarction, stroke, coronary interventions, heart failure, duplication of creatinine [ Time Frame: 18 months ]
|Study Start Date:||July 2010|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
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
Oral losartan up to 100 mg daily, once a day, for 18 month
Oral losartan up to 100 mg daily fo 18 months
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971165
|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|
|Study Chair:||Flávio D Fuchs, MD, PhD||Hospital de Clínicas de Porto Alegre|