NCT00970931: PREVER

Prevention of Hypertension in Patients With Pre-hypertension: PREVER-prevention Study

Completed Phase 3 Last updated 11 February 2015

What this trial tests

Phase 3 trial testing Chlorthalidone plus amiloride in Pre-hypertension in 730 participants. Completed in 1 September 2014.

Timeline

1 July 2010

Primary endpoint
1 September 2014

1 September 2014

Quick facts

Lead sponsor	Hospital de Clinicas de Porto Alegre
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	730
Start date	1 July 2010
Primary completion	1 September 2014
Estimated completion	1 September 2014
Sites	2 locations across Brazil

Drugs / interventions tested

• Chlorthalidone plus amiloride — full drug profile →
• placebo

Conditions studied

• Pre-hypertension — all drugs for Pre-hypertension →
• Hypertension — all drugs for Hypertension →
• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

Adults 30 to 70, any sex, with Pre-hypertension or Hypertension. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of hypertension, by blood pressure ≥ 140/90 mmHg in individuals without diabetes or ≥ 135/85 mmHg in participants with diabetes.
  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 months

Sponsor's own description

The incidence of hypertension in individuals with pre-hypertension was 80% in ten years in a study conducted in Southern Brazil. The effectiveness of non-drug interventions to prevent hypertension is low in the long term. It may be hypothesized that a population-based drug intervention could reduce relevantly the burden of hypertension and cardiovascular disease.

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 with this objective is therefore recommendable in Brazil, in order to support a plan of precocious intervention in individuals with pre-hypertension. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of Chlorthalidone Plus Amiloride for the Prevention of Hypertension: The PREVER-Prevention Randomized Clinical Trial.
   Fuchs SC, Poli-de-Figueiredo CE, Figueiredo Neto JA, Scala LC, et al · · 2016 · cited 48× · PMID 27965209 · DOI 10.1161/jaha.116.004248
2. Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial.
   Fuchs FD, Fuchs SC, Moreira LB, Gus M, et al · · 2011 · cited 22× · PMID 21375762 · DOI 10.1186/1745-6215-12-65
3. Electrocardiographic Left Ventricular Mass Trajectories and the Effects of Treatment in Patients at Different Stages of Hypertension.
   Fuchs FD, Valter LK, Tavares AL, Camilo BP, et al · · 2025 · PMID 40217763 · DOI 10.3390/jcm14072313