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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Servier
Information provided by (Responsible Party):
Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT00461903
First received: April 16, 2007
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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
Essential Hypertension
Atrial Fibrillation
Drug: Coversyl (perindopril)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • The primary efficacy endpoint will be time to first sustained recurrence of AF. [ Time Frame: 12 months follow-up ] [ Designated as safety issue: Yes ]
    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). [ Time Frame: 6 months follow-up ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 320
Study Start Date: December 2007
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sugar pill Drug: Coversyl (perindopril)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461903

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Servier
Investigators
Principal Investigator: Mario Talajic, MD Montreal Heart Institute
  More Information

Publications:
Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT00461903     History of Changes
Other Study ID Numbers: IC4-9490-123-CAN
Study First Received: April 16, 2007
Last Updated: April 22, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Montreal Heart Institute:
essential hypertension
symptomatic paroxysmal or persistent atrial fibrillation

Additional relevant MeSH terms:
Hypertension
Atrial Fibrillation
Recurrence
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Disease Attributes
Perindopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014