NCT00971165: PREVER

A Comparison Between Diuretics and Angiotensin-receptor Blocker Agents in Patients With Stage I Hypertension: PREVER-treatment Study

Completed Phase 3 Last updated 11 February 2015

What this trial tests

Phase 3 trial testing losartan in Hypertension in 655 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	treatment
Enrollment	655
Start date	1 July 2010
Primary completion	1 September 2014
Estimated completion	1 September 2014
Sites	2 locations across Brazil

Drugs / interventions tested

• losartan (losartan) — full drug profile →
• Chlorthalidone plus amiloride — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →
• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

40 and older, any sex, with Hypertension or Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

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

• 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

Sponsor's own description

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.

Publications & conference data

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

1. The Epithelial Sodium Channel-An Underestimated Drug Target.
   Lemmens-Gruber R, Tzotzos S. · · 2023 · cited 19× · PMID 37175488 · DOI 10.3390/ijms24097775
2. Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension: results from the PREVER-treatment randomized trial.
   Fuchs FD, Scala LC, Vilela-Martin JF, de Mello RB, et al · · 2016 · cited 15× · PMID 26938814 · DOI 10.1097/hjh.0000000000000837
3. A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): study protocol for a randomized double-blind controlled trial.
   Fuchs FD, Fuchs SC, Moreira LB, Gus M, et al · · 2011 · cited 7× · PMID 21349192 · DOI 10.1186/1745-6215-12-53
4. Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial.
   Fuchs FD, Scala LCN, Vilela-Martin JF, Whelton PK, et al · · 2021 · cited 5× · PMID 33047257 · DOI 10.1007/s00592-020-01611-8
5. 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