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Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence

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ClinicalTrials.gov Identifier: NCT01016431
Recruitment Status : Unknown
Verified November 2009 by Federico II University.
Recruitment status was:  Recruiting
First Posted : November 19, 2009
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Federico II University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Heart Failure Exercise Tolerance Other: Rate-adaptive pacemaker programming Other: VVI at 40 bpm Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : November 2009
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Peak Oxygen consumption on cardiopulmonary exercise testing [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Peak Heart Rate on Cardiopulmonary exercise testing [ Time Frame: 1 month ]
  2. Quality of life as assessed by Minnesota Living with Heart Failure and SF-36 Questionnaires [ Time Frame: 1 month ]
  3. Heart Rate Variability on Holter Monitoring [ Time Frame: 1 month ]
  4. Acute Change in Peak Oxygen Consumption after reprogrammation [ Time Frame: 1 hour ]
  5. NT-proBNP levels [ Time Frame: 1 Month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016431


Contacts
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Contact: Serafino Fazio, MD +390817463737 fazio@unina.it
Contact: Guido Carlomagno, MD guido.carlomagno@yahoo.it

Locations
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Italy
Federico II University - Department of Internal Medicine Recruiting
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University
More Information
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Responsible Party: Prof. Serafino Fazio, Federico II University
ClinicalTrials.gov Identifier: NCT01016431    
Other Study ID Numbers: CHRON-INC-09
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: November 2009
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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases