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
  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

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Peak Oxygen consumption on cardiopulmonary exercise testing [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016431

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

Locations
Italy
Federico II University - Department of Internal Medicine Recruiting
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University
  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 September 16, 2014