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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rate adaptive | Experimental | Patients will have their ICD programmed in a AAI-R mode, with peak atrial rate set at 85% of age-adjusted predicted maximal HR |
|
| Control | Active Comparator | ICDs will be programmed in the usual VVI backup pacing mode at 40 bpm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rate-adaptive pacemaker programming | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Oxygen consumption on cardiopulmonary exercise testing | 1 month |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serafino Fazio, MD | Contact | +390817463737 | fazio@unina.it | |
| Guido Carlomagno, MD | Contact | guido.carlomagno@yahoo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II University - Department of Internal Medicine | Recruiting | Naples | 80100 | Italy |
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| VVI at 40 bpm | Other | ICDs will be programmed in VVI mode at 40 bpm |
|
| Heart Rate Variability on Holter Monitoring |
| 1 month |
| Acute Change in Peak Oxygen Consumption after reprogrammation | 1 hour |
| NT-proBNP levels | 1 Month |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018754 | Ventricular Dysfunction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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