Efficacy of Perindopril to Prevent Recurrence of Atrial Fibrillation in Patients With Essential Hypertension

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montreal Heart Institute
• Collaborator: Servier
• Treatments: Perindopril

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.