Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Federico II University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT01016431
First received: November 18, 2009
Last updated: June 24, 2011
Last verified: November 2009
History of Changes

November 18, 2009
June 24, 2011
November 2009
July 2012   (final data collection date for primary outcome measure)
Peak Oxygen consumption on cardiopulmonary exercise testing [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01016431 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence
Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Heart Failure
  • Exercise Tolerance
  • 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
  • Other: VVI at 40 bpm
    ICDs will be programmed in VVI mode at 40 bpm
  • 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
    Intervention: Other: Rate-adaptive pacemaker programming
  • Active Comparator: Control
    ICDs will be programmed in the usual VVI backup pacing mode at 40 bpm
    Intervention: Other: VVI at 40 bpm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
August 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Serafino Fazio, MD +390817463737 fazio@unina.it
Contact: Guido Carlomagno, MD guido.carlomagno@yahoo.it
Italy
 
NCT01016431
CHRON-INC-09
No
Prof. Serafino Fazio, Federico II University
Federico II University
Not Provided
Not Provided
Federico II University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP