Exercise Tolerance, Heart Failure
Conditions
Keywords
cardiac pacing, heart failure, oxygen consumption, ventricular dysfunction, left, exercise tolerance, chronotropic incompetence, pacemaker programming
Brief summary
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.
Interventions
OTHERRate-adaptive pacemaker programming
The ICD will be programmed in a AAI-R mode, with peak atrial stimulation rate set at 85% of maximal predicted heart rate, and ongoing protection VVI backup at 40 bpm
OTHERVVI at 40 bpm
ICDs will be programmed in VVI mode at 40 bpm
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* NYHA II/III chronic heart failure on optimal medical therapy * Sinus Rhythm * Left ventricular ejection fraction less than 40 % * Chronotropic incompetence on maximal exercise testing (maximum heart rate \< 80% of predicted value) * Age 18-75 * carrier of dual chamber ICD device * Informed Consent
Exclusion criteria
* Unable to perform cardiopulmonary exercise testing (for any reason) * Absolute contraindication to maximal exercise testing * Moderate to severe anemia (Hb\<10 g/dL) * Diagnosis of Sick Sinus Syndrome or high-degree atrioventricular block * recent hospitalization for acute decompensated heart failure (\<1 month) * recent acute coronary syndrome (\<3 months) * Active neoplastic disease * Active myocarditis / endocarditis * Acute decompensated heart failure during study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Oxygen consumption on cardiopulmonary exercise testing | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Peak Heart Rate on Cardiopulmonary exercise testing | 1 month |
| Quality of life as assessed by Minnesota Living with Heart Failure and SF-36 Questionnaires | 1 month |
| Heart Rate Variability on Holter Monitoring | 1 month |
| Acute Change in Peak Oxygen Consumption after reprogrammation | 1 hour |
| NT-proBNP levels | 1 Month |
Countries
Italy
Contacts
Primary ContactSerafino Fazio, MD
Backup ContactGuido Carlomagno, MD
Outcome results
None listed