Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence
NCT ID: NCT01016431
Last Updated: 2011-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2009-11-30
2012-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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
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
Control
ICDs will be programmed in the usual VVI backup pacing mode at 40 bpm
VVI at 40 bpm
ICDs will be programmed in VVI mode at 40 bpm
Interventions
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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
VVI at 40 bpm
ICDs will be programmed in VVI mode at 40 bpm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Federico II University
Locations
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Federico II University - Department of Internal Medicine
Naples, , Italy
Countries
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Central Contacts
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Other Identifiers
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CHRON-INC-09
Identifier Type: -
Identifier Source: org_study_id
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