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Right vEntricular Dysfunction in tEtralogy of Fallot: INhibition of the rEnin-angiotensin-aldosterone system (REDEFINE) trial: Rationale and design of a randomized, double-blind, placebo-controlled clinical trial.
- Source :
-
American heart journal [Am Heart J] 2017 Apr; Vol. 186, pp. 83-90. Date of Electronic Publication: 2017 Jan 02. - Publication Year :
- 2017
-
Abstract
- Renin-angiotensin-aldosterone system (RAAS) inhibition with angiotensin II receptor blockers or angiotensin-converting enzyme inhibitors is beneficial in patients with acquired left ventricular dysfunction. Adult patients with tetralogy of Fallot (TOF) with right ventricular (RV) dysfunction are at high risk for heart failure, arrhythmias, and sudden cardiac death. However, the efficacy of RAAS inhibition has not been established in these patients.<br />Methods: The REDEFINE is an investigator-initiated, multicenter, prospective, randomized, double-blind, placebo-controlled trial to study the effects of the angiotensin II receptor blocker losartan (target dosage of 150 mg once daily) in adult patients with TOF. Patients with RV dysfunction in the absence of severe valvular dysfunction are eligible for inclusion. The primary end point is the change in RV ejection fraction after 18 to 24 months, as measured by cardiovascular magnetic resonance imaging. In addition, laboratory measurements, echocardiography, and cardiopulmonary exercise testing are performed.<br />Conclusion: The REDEFINE trial will study the effects of RAAS inhibition with losartan in TOF patients with RV dysfunction.<br /> (Copyright © 2016 Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Double-Blind Method
Female
Humans
Male
Prospective Studies
Tetralogy of Fallot diagnosis
Ventricular Dysfunction, Right diagnosis
Angiotensin II Type 1 Receptor Blockers therapeutic use
Losartan therapeutic use
Renin-Angiotensin System drug effects
Tetralogy of Fallot drug therapy
Tetralogy of Fallot physiopathology
Ventricular Dysfunction, Right drug therapy
Ventricular Dysfunction, Right physiopathology
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6744
- Volume :
- 186
- Database :
- MEDLINE
- Journal :
- American heart journal
- Publication Type :
- Academic Journal
- Accession number :
- 28454836
- Full Text :
- https://doi.org/10.1016/j.ahj.2016.12.014