TY - JOUR
T1 - 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
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.
PY - 2017
Y1 - 2017
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. 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. 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. 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. The REDEFINE trial will study the effects of RAAS inhibition with losartan in TOF patients with RV dysfunction
U2 - https://doi.org/10.1016/j.ahj.2016.12.014
DO - https://doi.org/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 -