Heart Failure Clinical Trial
Official title:
Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence
Chronotropic incompetence consists of an insufficient increase in heart rate during effort,
and its presence is recognized as a common feature in patients with heart failure due to
left ventricular systolic dysfunction, apparently suggesting a worse prognosis. Little is
known about the possible benefits of its reversal in such patients.
The investigators working hypothesis is that the modulation of chronotropic response, as
obtained by means of atrial rate-adaptive pacing may improve functional capacity in persons
with chronic heart failure and chronotropic incompetence.
To explore this hypothesis,the investigators will enroll 20 patients with NYHA II/III heart
failure, low left ventricular ejection fraction (<40%) and chronotropic incompetence
(Maximal heart rate <80% of predicted value in a symptom-limited incremental test), who
already underwent implantation of dual-chamber implantable defibrillator for prevention of
sudden cardiac death. The study will have a randomized, double-blind, cross-over design.
The procedures, to be carried out at one month from each reprogramming (VVI backup pacing
vs. AAI-R "active" pacing), will comprise: blood sampling for NT-proBNP, incremental
symptom-limited cardiopulmonary exercise testing (CPX), constant-workload cardiopulmonary
test (50% of max WR), quality-of-life questionnaire, 24-hour ECG monitoring.
The primary end-point will be peak oxygen consumption on CPX. Secondary end-points will
include acute response to reprogramming, and data derived from constant-WR tests, Holter
monitoring and QoL.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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