TY - JOUR
T1 - Right vEntricular Dysfunction in tEtralogy of Fallot
T2 - INhibition of the rEnin-angiotensin-aldosterone system (REDEFINE) trial: Rationale and design of a randomized, double-blind, placebo-controlled clinical trial
AU - Bokma, Jouke P.
AU - Winter, Michiel M.
AU - Kornaat, Esmée M.
AU - Vliegen, Hubert W.
AU - van Dijk, Arie P.
AU - van Melle, Joost P.
AU - Meijboom, Folkert J.
AU - Post, Martijn C.
AU - Berbee, Jacqueline K.
AU - Zwinderman, Aeilko H.
AU - Mulder, Barbara J.M.
AU - Bouma, Berto J.
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2017/4/1
Y1 - 2017/4/1
N2 - 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. 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. Conclusion The REDEFINE trial will study the effects of RAAS inhibition with losartan in TOF patients with RV dysfunction.
AB - 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. 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. Conclusion The REDEFINE trial will study the effects of RAAS inhibition with losartan in TOF patients with RV dysfunction.
KW - Adult
KW - Angiotensin II Type 1 Receptor Blockers
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Losartan
KW - Male
KW - Prospective Studies
KW - Renin-Angiotensin System
KW - Tetralogy of Fallot
KW - Ventricular Dysfunction, Right
KW - Multicenter Study
KW - Randomized Controlled Trial
UR - http://www.scopus.com/inward/record.url?scp=85012186801&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2016.12.014
DO - 10.1016/j.ahj.2016.12.014
M3 - Article
C2 - 28454836
SN - 0002-8703
VL - 186
SP - 83
EP - 90
JO - American Heart Journal
JF - American Heart Journal
ER -