Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Exercise Tolerance |
Other: Rate-adaptive pacemaker programming Other: VVI at 40 bpm |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence |
- Peak Oxygen consumption on cardiopulmonary exercise testing [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Peak Heart Rate on Cardiopulmonary exercise testing [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Quality of life as assessed by Minnesota Living with Heart Failure and SF-36 Questionnaires [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Heart Rate Variability on Holter Monitoring [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Acute Change in Peak Oxygen Consumption after reprogrammation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- NT-proBNP levels [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rate adaptive
Patients will have their ICD programmed in a AAI-R mode, with peak atrial rate set at 85% of age-adjusted predicted maximal HR
|
Other: Rate-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
|
|
Active Comparator: Control
ICDs will be programmed in the usual VVI backup pacing mode at 40 bpm
|
Other: VVI at 40 bpm
ICDs will be programmed in VVI mode at 40 bpm
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Serafino Fazio, MD | +390817463737 | fazio@unina.it |
| Contact: Guido Carlomagno, MD | guido.carlomagno@yahoo.it |
| Italy | |
| Federico II University - Department of Internal Medicine | Recruiting |
| Naples, Italy, 80100 | |
More Information
No publications provided
| Responsible Party: | Prof. Serafino Fazio, Federico II University |
| ClinicalTrials.gov Identifier: | NCT01016431 History of Changes |
| Other Study ID Numbers: | CHRON-INC-09 |
| Study First Received: | November 18, 2009 |
| Last Updated: | June 24, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Federico II University:
|
cardiac pacing heart failure oxygen consumption ventricular dysfunction |
left, exercise tolerance chronotropic incompetence pacemaker programming |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013