A Phase 3 interventional study of Perindopril in Essential Hypertension and Atrial Fibrillation, sponsored by Montreal Heart Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by Montreal Heart Institute · Phase 3, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 316 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Patients must have had at least one episode of symptomatic paroxysmal or persistent atrial fibrillation within the preceding six months:
Exclusion Criteria:
Sugar pill manufactued to mimic perindopril
Drug: Perindopril
Perindopril (coversyl) 4 mg tablets
Drug: Perindopril
Perindopril 4 mg or matching placebo , 1 tablet administrated once daily for the first 2 weeks. If tolarable, dosage increased to 8mg/day until the end of the study (
Also known as: Coversyl
The primary efficacy endpoint will be time to first sustained recurrence of AF.
1 month treatment adjustment 3 months of endpoint follow-up - M4 6 months of endpoint follow-up - M7 12 months of endpoint follow-up - M13
Time frame: 12 months follow-up
Secondary efficacy endpoints will be the proportion of patients without AF throughout the 6 months of follow-up, number of documented relapses of AF, and health care resource utilization (including hospitalisations for AF and cardioversions).
Secondary efficacy endpoints will be the proportion of patients without AF throughout the 6 months of follow-up,number of documented relapses of AF, and health care resources utilization (including hospitalisations for AF and cardioversion)
Time frame: 6 months follow-up
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Montreal Heart Institute