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Efficacy of Perindopril to Prevent Recurrence of Atrial Fibrillation in Patients With Essential Hypertension (CTAF-2)

Primary Purpose

Essential Hypertension, Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Perindopril
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring essential hypertension, symptomatic paroxysmal or persistent atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo (for perindopril)

Perindopril

Arm Description

Sugar pill manufactued to mimic perindopril

Perindopril (coversyl) 4 mg tablets

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
April 16, 2007
Last Updated
February 20, 2020
Sponsor
Montreal Heart Institute
Collaborators
Servier
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1. Study Identification

Unique Protocol Identification Number
NCT00461903
Brief Title
Efficacy of Perindopril to Prevent Recurrence of Atrial Fibrillation in Patients With Essential Hypertension
Acronym
CTAF-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montreal Heart Institute
Collaborators
Servier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Atrial Fibrillation
Keywords
essential hypertension, symptomatic paroxysmal or persistent atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (for perindopril)
Arm Type
Placebo Comparator
Arm Description
Sugar pill manufactued to mimic perindopril
Arm Title
Perindopril
Arm Type
Active Comparator
Arm Description
Perindopril (coversyl) 4 mg tablets
Intervention Type
Drug
Intervention Name(s)
Perindopril
Other Intervention Name(s)
Coversyl
Intervention Description
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 (
Primary Outcome Measure Information:
Title
The primary efficacy endpoint will be time to first sustained recurrence of AF.
Description
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 Outcome Measure Information:
Title
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).
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Talajic, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12493255
Citation
Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8. Erratum In: Lancet. 2003 Mar 22;361(9362):1060.
Results Reference
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Efficacy of Perindopril to Prevent Recurrence of Atrial Fibrillation in Patients With Essential Hypertension

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