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Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments using Ramipril and Placebo for patients with Atrial Fibrillation or Atrial Flutter

Research Study Title

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

Purpose

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.

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Duration

92 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (1)

Country State City Zip Facility and Contact
France Saint-etienne 42 055 CHU de Saint-Etienne

Antoine DA COSTA, MD PhD
Principal Investigator

CĂ©cile ROMEYER-BOUCHARD, MD
Sub-Investigator

Contact

Antoine DA COSTA, PhD MD
+33 (0) 4 77 82 83 40

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT00736294

Date Last Changed: January 17, 2014

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