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Sponsors and Collaborators: |
Montreal Heart Institute Servier |
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Information provided by: | Montreal Heart Institute |
ClinicalTrials.gov Identifier: | NCT00461903 |
The purpose of this 7- to 13-month study is to determine the efficacy of 8 mg/day oral perindopril to prevent the recurrence of atrial fibrillation (AF) in patients with essential hypertension.
Condition | Intervention | Phase |
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Essential Hypertension Atrial Fibrillation |
Drug: Coversyl (perindopril) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Double-Blind Placebo-Controlled Study to Determine the Efficacy of 8 mg/Day Oral Perindopril to Prevent the Recurrence of Atrial Fibrillation in Patients With Essential Hypertension |
Estimated Enrollment: | 320 |
Estimated Study Completion Date: | August 2008 |
Hypertension affects approximately 50 million individuals in the United States and approximately 1 billion individuals worldwide. As the population ages, the prevalence of hypertension is expected to increase even further unless broad and effective preventive measures are implemented. Recent data from the Framingham Heart Study suggest that individuals who are normotensive at 55 years of age have a 90% lifetime risk for developing hypertension. The relationship between blood pressure (BP) and risk of cardiovascular disease (CVD) events is continuous, consistent, and independent of other risk factors. The higher the BP, the greater is the chance of myocardial infarction, heart failure (HF), stroke, and kidney disease.
Atrial fibrillation (AF) is also a major health problem and has been described as one of two emerging cardiovascular epidemics at the turn of the century. It is the most frequent cardiac arrhythmia, affecting 5% of individuals aged > 65 years, and it is associated with an increased risk of stroke and a doubling of all-cause mortality. The loss of effective atrial contraction may result in impaired cardiac performance, reduced exercise tolerance and congestive heart failure. In addition, patients with atrial fibrillation often have disabling palpitations.
Perindopril (Coversyl) is an angiotensin-converting enzyme (ACE) inhibitor with demonstrated efficacy in controlling hypertension. There are several lines of evidence suggesting that ACE inhibition may reduce the incidence of new-onset AF as well as AF recurrences.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have had at least one episode of symptomatic paroxysmal or persistent atrial fibrillation within the preceding six months:
Exclusion Criteria:
Contact: Sonia Gagnon, BSc | 514-461-1300 ext 2038 | sonia.gagnon@mhicc.org |
Canada, Quebec | |
Montreal Heart Institute | |
Montreal, Quebec, Canada, H1T 1C8 |
Principal Investigator: | Mario Talajic, MD | Montreal Heart Institute |
Study ID Numbers: | IC4-9490-123-CAN |
Study First Received: | April 16, 2007 |
Last Updated: | July 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00461903 |
Health Authority: | Canada: Ethics Review Committee |
essential hypertension symptomatic paroxysmal or persistent atrial fibrillation |
Perindopril Heart Diseases Vascular Diseases Essential hypertension |
Atrial Fibrillation Recurrence Arrhythmias, Cardiac Hypertension |
Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |