Status:
COMPLETED
Efficacy of Perindopril to Prevent Recurrence of Atrial Fibrillation in Patients With Essential Hypertension
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
Servier
Conditions:
Essential Hypertension
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Patients must be age 18 years or older.
- Patients may be either male or female without childbearing potential (or with adequate contraception).
- Patients must have a current diagnosis of essential hypertension with systolic blood pressure (SBP) ≤ 160 mmHg and diastolic blood pressure (DBP) ≤ 100 mmHg at the time of inclusion visit AND
- Patients must have had at least one episode of symptomatic paroxysmal or persistent atrial fibrillation within the preceding six months:
- With an indication for cardioversion in the case of persistent AF
- With electrocardiogram (ECG) documentation of AF
- With duration of an AF episode of at least 10 minutes
Exclusion
- Unlikely to co-operate in the study
- Pregnancy, breastfeeding, or possibility of becoming pregnant during the study (patients must have adequate contraception as determined by the investigator).
- Alcoholism or drug abuse
- Participation in another study at the same time or within 30 days of randomisation.
- Left ventricular systolic dysfunction with an ejection fraction of 45% or less
- Myocardial infarction within the past month prior to the selection visit
- Cardiac or thoracic surgery within the past 3 months or likely to be performed during the trial
- Chronic AF (continuously present for \> 6 months)
- AF secondary to an acute reversible condition (e.g. post-operative atrial fibrillation, hyperthyroidism)
- Currently requiring class I or class III anti-arrhythmic drug therapy (for atrial fibrillation or any other arrhythmia)
- Any medical condition that makes the patient an unsuitable candidate in the investigator's opinion
- Any medical condition requiring ACE inhibitor or angiotensin-receptor blocker therapy (e.g. diabetes, known proteinuria of more than 300 mg per day)
- Renal insufficiency with serum creatinine of 180 μmol/L or greater
- Known bilateral renal artery stenosis
- Serum potassium of 5.0 mmol/L or greater on recent laboratory exam
- Positive pregnancy test (beta human chorionic gonadotropin \[HCG\] performed in women of childbearing potential)
- Known intolerance to ACE inhibitor
- Impossibility to discontinue certain treatments at selection visit
- Known contraindication(s) to perindopril
- Severe known liver disease including cirrhosis, biliary obstruction or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation more than 3 times the upper limit of normal
- Use of ACE inhibitor or angiotensin-receptor blocker in the 3 months before the inclusion visit
- Severely uncontrolled hypertension with SBP \> 160 mmHg or DBP \> 100 mmHg at the inclusion visit.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT00461903
Start Date
December 1 2007
End Date
September 1 2015
Last Update
February 21 2020
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8