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

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-74rr6s
• Date of registration: 02/03/2011
• Primary sponsor: Hospital de Clínicas de Porto Alegre - Brazil
• Public title: PREVER Study: Efficacy of the combination of Chlorthalidone and Amiloride versus placebo in the prevention of hypertension in patients with prehypertension PREVER 1 Study
• Scientific title: PREVER Study: Efficacy of the combination of Chlorthalidone and Amiloride versus placebo in the prevention of hypertension in patients with prehypertension PREVER 1 Study - PREVER 1 Study: Prevention of Cardiovascular outcomes in patients with prehypertension
• Date of first enrolment: 01/02/2011
• Target sample size: 1350
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-74rr6s/
• Study design: Randomized Clinical Trial, double-blind, placebo controled trial

Countries of recruitment

Brazil

Contacts

• Name: Flávio Fuchs
• Affiliation: Hospital de Clínicas de Porto Alegre

• Name: Flávio Fuchs
• Affiliation: Hospital de Clínicas de Porto Alegre

Key inclusion & exclusion criteria

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);


Age minimum: 30Y
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

Prehypertension
I10

Intervention(s)

Drug: Chlorthalidone 12,5 mg plus amiloride 2,5 mg once daily for 18 months
Drug: placebo once daily for 18 months

Primary Outcome(s)

Adverse events.

Incidence of hypertension, by blood pressure greater or equal to 140/90 mmHg.

Secondary Outcome(s)

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

Secondary ID(s)

08621

NCT00970931

Source(s) of Monetary Support

Hospital de Clínicas de Porto Alegre - Brazil

FINEP - Brazil

Secondary Sponsor(s)

FINEP - Brazil