PREVER Study: Efficacy of the combination of Chlorthalidone and Amiloride versus placebo in the prevention of hypertension in patients with prehypertension PREVER 1 Study

Phase 3

Recruiting

• Conditions: Prehypertension

• Registration Number: RBR-74rr6s
• Lead Sponsor: Hospital de Clínicas de Porto Alegre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

I. individuals with 30 to 70 years of age
II. Systolic Arterial Pressure 120-139 mmHg or Diastolic Arterial Pressure 80-89 mmHg;

Exclusion Criteria

I. Previous diagnosis of hypertension or use of antihypertensive drugs;
II. Allergies to Chlorthalidone Amiloride;
III. Known cardiovascular disease (previous Miocardial Infarction, previous stroke, heart failure or clinical manifestations, for example, current or previous angina, intermittent claudication ...);
IV. Chronic diseases that limit the participation or the prospect of life (such as cancer, rheumatic disease, disability, etc.);
V. Analgesics or anti-inflammatory use for 30 days or more;
VI. Inability to measure blood pressure;
VII. Difficulty in understanding that limits participation in the study;
VIII. IF WOMEN: Pregnant or planning to become pregnant in the next two years;
IX. Patients who have participated in other randomized trials (the last six months);

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hypertension, by blood pressure greater or equal to 140/90 mmHg.<br>;Adverse events. <br>

Secondary Outcome Measures

Name	Time	Method
I. All-cause mortality<br>II. Incidence of Coronary Artery Disease (Acute Coronary Syndrome, need for revascularization, sudden death)<br>III. Fatal and nonfatal stroke<br>IV. Heart failure (requiring hospitalization)<br>V. Duplication of plasma levels of creatinine or need for dialysis<br>VI. Incidence of diabetes mellitus.<br>VII. Microalbuminuria<br>VIII. Hypokalemia<br>IX. Hyperuricemia<br>X. Left ventricular hypertrophy on Eletrocardiogram