Heart Failure With Reduced Ejection Fraction Clinical Trial
Official title:
CompaRative Study of the Effects of Left ventriculAr and Biventricular Pacing on inDices of cArdiac Function and Clinical Course of Heart Failure PatienTs: Rationale and Design of the READAPT Randomized Trial
Randomized trial of adult patients to study the effects of preferential left ventricular pacing on ventriculoarterial coupling of both systemic and pulmonary circulation, indices of systolic and diastolic function of both ventricles, and clinical course of patients with advances dyssynchronous heart failure.
Study hypothesis is that preferential left ventricular (LV) pacing, delivered by means of the
AdaptivCRT® algorithm and in conjunction with automated V-V delay adjustments, will lead to
improvements over standard biventricular pacing (BVP) in the function of all cardiac
chambers, reduce arrhythmic burden, improve ventricular-arterial coupling (VAC), and patient
functional status. It would be interesting to study what changes in right-side VAC (RVAC) can
be appreciated with the activation of the preferential LV pacing algorithm and how they
relate to each other, i.e. whether LV is driven towards maximizing output whilst RV shifts to
optimizing energy efficiency.
READAPT is a single-center, prospective, randomized trial of heart failure patients eligible
for CRT according to current European heart failure guidelines. Informed written consent is
required from all study participants.
Adult (aged 18-80 years old), consenting patients with any cardiomyopathy type, diagnosed at
least 6 months prior (to exclude recent myocarditis cases that may remit and confound
outcomes), on optimal medical therapy for at least 3 months, and an existing I/IIa indication
for a cardiac resynchronization therapy - defibrillator (CRT-D) device will be enrolled and
randomized into 2 groups, one receiving standard CRT (Group 1 - G1), and one with activation
of the preferential LV pacing algorithm (Group 2 - G2). Enrollment date will amount to the
baseline assessment date, with device implantation occurring preferably within 48 hours.
READAPT will include patients with both new CRT-D implantation and an upgrade from an
existing defibrillator or pacemaker with no prior left ventricular lead placement.
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