Hypertension Prevention in Pre-Hypertensive Individuals (PREVER)
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ClinicalTrials.gov Identifier: NCT00970931 |
Recruitment Status
:
Completed
First Posted
: September 3, 2009
Last Update Posted
: February 12, 2015
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 2, 2009 | ||||||
First Posted Date ICMJE | September 3, 2009 | ||||||
Last Update Posted Date | February 12, 2015 | ||||||
Study Start Date ICMJE | July 2010 | ||||||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00970931 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
fatal or major cardiovascular events: myocardial infarction, stroke, coronary interventions, heart failure, duplication of creatinine [ Time Frame: 18 months ] | ||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Hypertension Prevention in Pre-Hypertensive Individuals | ||||||
Official Title ICMJE | Prevention of Hypertension in Patients With Pre-hypertension: PREVER-prevention Study | ||||||
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. |
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Detailed Description | This is a nation-based trial, with 24 clinical centers distributed in 9 States. A Coordinating Committee is responsible for the elaboration of this proposal and for the main decisions of the trial. The organizational chart of the study will include an executive Committee, a safety committee, outcome committee, lab and EKG centers, and the research units Cardiovascular disease (CVD) is already the leading cause of death in Brazil. High blood pressure is the major risk factor for CVD. The risks start at blood pressure values as lower as 115/75 mmHg but increase exponentially and confer higher absolute risks with blood pressure higher than 140/90 mmHg. 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 treatment of individuals with pre-hypertension and cardiovascular disease was demonstrated in several clinical trials. In face of the higher incidence of hypertension in individuals with pre-hypertension, the low effectiveness of non-drug interventions and the risks for cardiovascular events and end-organ damage at lower blood pressure levels, it may be advisable to start blood pressure drugs at low doses at this point of the inexorable elevation of blood pressure with aging. Research questions
Methods Design: randomized, double-blind, clinical trial, controlled by placebo. Eligible participants: individuals with 30 to 70 years of age with pre-hypertension. Exclusion criteria: low life expectancy, other indications for the use of diuretics, such as cardiovascular disease, intolerance to the study drugs, pregnancy. Random allocation: by a computer generated list, stratified by center. Interventions: Chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. Primary outcomes:
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
730 | ||||||
Original Estimated Enrollment ICMJE |
1250 | ||||||
Actual Study Completion Date | September 2014 | ||||||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 30 Years to 70 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Brazil | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00970931 | ||||||
Other Study ID Numbers ICMJE | GPPG08621-1 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Flávio Danni Fuchs, Hospital de Clinicas de Porto Alegre | ||||||
Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||||
Collaborators ICMJE | Financiadora de Estudos e Projetos | ||||||
Investigators ICMJE |
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PRS Account | Hospital de Clinicas de Porto Alegre | ||||||
Verification Date | February 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |