Skip to content

Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter

Prevention of Atrial Fibrillation by the Prescription of Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00736294
Acronym
PREFACE
Enrollment
198
Registered
2008-08-15
Start date
2008-07-31
Completion date
2015-03-31
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Flutter

Keywords

Catheter Ablation, Radiofrequency, Angiotensin-Converting Enzyme Inhibitors

Brief summary

Atrial Flutter \[AFL\] is a relatively frequent arrhythmia, considered as benign, but associated with both invalidating symptoms and thromboembolic risk. The objective of the treatment consists to on the one hand the sinus rhythm \[SR\] restoration and on the other hand the prevention of the long-term recurrence. In this clinical setting, AFL radiofrequency ablation \[RFA\] became the first line therapy due to its both high effectiveness and safety. The effectiveness of AFL RFA is attenuated by the subsequent risk of atrial fibrillation \[AFib\] close to 25% at 1 year. This risk of subsequent AFib is related to the common substrate between both arrhythmias. When AFib occurs, the interest to maintain the SR is still required, even if recent studies did not show a significant difference in term of total mortality between rate or rhythm control strategies \[AFFIRM, RACE and PIAF studies\]. The studies published underlined the anti-arrhythmic drugs limits in patients with both arrhythmias \[AFib and AFL\]. After years centered on the mechanisms and the electric treatments of AFib, researchers are nowadays focusing on the study's evaluation of the atrial tissue substrate. Accordingly, the renin-angiotensin system role was investigated in many works. Indeed, angiotensin II plays a role in the modification of atrial pressure and in the fibers stretching \[stretch\], conditions required for the development of AFib. Angiotensin II is also a factor implied in the tissue fibrosis leading to tissue proliferation and collagen alteration. These mechanisms lead to atria cells conduction disorders and refractory periods modification. Moreover, the enzyme of conversion expression and the angiotensin II receptors deterioration were observed in patients with AFib. This brings to the concept of AFib treatment while interfering on tissue remodeling by the way of renin-angiotensin system. Drugs such as the angiotensin converting enzyme inhibition \[ACEI\] may reduce AFib in patients with heart failure. No randomized study so far has compared the ACEI drugs against placebo among high-risk patients of AFib in post AFL RFA area. On the basis of experimental and clinical study, the investigators seek to evaluate the ACEI use in the prevention of AFib in an AFL post RFA ablation.

Detailed description

The main goal of this study is to compare within 12 months, the effectiveness of an ACEI \[Ramipril\] versus placebo on the prevention of AFib after AFL RFA. This study is a randomized, prospective, double blind, multicenter study comparing ramipril vs. placebo in 2 parallel groups.

Interventions

DRUGRamipril

5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets

DRUGPlacebo

5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets

Sponsors

Sanofi
CollaboratorINDUSTRY
Ministry of Health, France
CollaboratorOTHER_GOV
LivaNova
CollaboratorINDUSTRY
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* first atrial flutter, or recurrence of atrial flutter * affiliated or a beneficiary of a social security category * treated by radiofrequency ablation (\< 72 h) * having signed the inform consent form

Exclusion criteria

* contra-indication to right catheterism * contra-indication to angiotensin converting enzym inhibitors * contra-indication to anticoagulation treatment * having already a angiotensin converting enzym inhibitor treatment * recent (\< 3 months) hearth failure with left ventricular ejection fraction \< 45% * pregnant women or breast-feeding * severe renal disease * serum potassium \> 5 mmol/l * requiring a antiarrythmic treatment

Design outcomes

Primary

MeasureTime frame
At least one relevant symptomatic or asymptomatic atrial fibrillation eventFrom D1 to M12

Secondary

MeasureTime frame
All relevant cardiovascular eventFrom D1 to M12
Secondary effects of the treatmentFrom D1 to M12

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026