Hypertension Prevention in Pre-Hypertensive Individuals
PREVER
Prevention of Hypertension in Patients With Pre-hypertension: PREVER-prevention Study
1 other identifier
interventional
730
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2010
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 12, 2015
February 1, 2015
4.2 years
September 2, 2009
February 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of hypertension, by blood pressure ≥ 140/90 mmHg in individuals without diabetes or ≥ 135/85 mmHg in participants with diabetes.
18 months
Adverse events.
18 months
Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG
18 months
Secondary Outcomes (1)
fatal or major cardiovascular events: myocardial infarction, stroke, coronary interventions, heart failure, duplication of creatinine
18 months
Study Arms (2)
placebo
PLACEBO COMPARATORchlortalidone-amiloride
EXPERIMENTALInterventions
Oral Chlorthalidone 12.5 mg plus amiloride 2.5 mg, once a day for 18 months
Eligibility Criteria
You may qualify if:
- individuals with 30 to 70 years of age with pre-hypertension
You may not qualify if:
- low life expectancy
- other indications for the use of diuretics, such as cardiovascular disease
- intolerance to the study drugs
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital de Clínicas de Porto Alegre, UFRGS
Porto Alegre, Rio Grande do Sul, 90035 903, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Related Publications (3)
Fuchs FD, Fuchs SC, Moreira LB, Gus M, Nobrega AC, Poli-de-Figueiredo CE, Mion D, Bortoloto L, Consolim-Colombo F, Nobre F, Coelho EB, Vilela-Martin JF, Moreno H Jr, Cesarino EJ, Franco R, Brandao AA, de Sousa MR, Ribeiro AL, Jardim PC, Neto AA, Scala LC, Mota M, Chaves H, Alves JG, Filho DC, Pereira e Silva R, Neto JA, Irigoyen MC, Castro I, Steffens AA, Schlatter R, de Mello RB, Mosele F, Ghizzoni F, Berwanger O. Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial. Trials. 2011 Mar 5;12:65. doi: 10.1186/1745-6215-12-65.
PMID: 21375762BACKGROUNDFuchs FD, Fuchs SC, Poli-de-Figueiredo CE, Figueiredo Neto JA, Scala LCN, Vilela-Martin JF, Moreira LB, Chaves H, Mota Gomes M, de Sousa MR, Silva RPE, Castro I, Cesarino EJ, Sousa ALL, Alves JG, Steffens AA, Brandao AA, Bortolotto LA, Afiune Neto A, Nobrega AC, Franco RS, Sobral Filho DC, Nobre F, Schlatter R, Gus M, De David CN, Rafaelli L, Sesin GP, Berwanger O, Whelton PK. Effectiveness of low-dose diuretics for blood pressure reduction to optimal values in prehypertension: a randomized clinical trial. J Hypertens. 2018 Apr;36(4):933-938. doi: 10.1097/HJH.0000000000001624.
PMID: 29227377DERIVEDFuchs SC, Poli-de-Figueiredo CE, Figueiredo Neto JA, Scala LC, Whelton PK, Mosele F, de Mello RB, Vilela-Martin JF, Moreira LB, Chaves H, Mota Gomes M, de Sousa MR, Silva RP, Castro I, Cesarino EJ, Jardim PC, Alves JG, Steffens AA, Brandao AA, Consolim-Colombo FM, de Alencastro PR, Neto AA, Nobrega AC, Franco RS, Sobral Filho DC, Bordignon A, Nobre F, Schlatter R, Gus M, Fuchs FC, Berwanger O, Fuchs FD. Effectiveness of Chlorthalidone Plus Amiloride for the Prevention of Hypertension: The PREVER-Prevention Randomized Clinical Trial. J Am Heart Assoc. 2016 Dec 13;5(12):e004248. doi: 10.1161/JAHA.116.004248.
PMID: 27965209DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Flávio D Fuchs, MD, PhD
Hospital de Clínics de Porto Alegre
- STUDY DIRECTOR
Sandra C Fuchs, MD, PhD
Hospital de Clínicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 3, 2009
Study Start
July 1, 2010
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
February 12, 2015
Record last verified: 2015-02