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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01016431
• Other study ID #: CHRON-INC-09
• Status: Recruiting
• Phase: Phase 4
• First received: November 18, 2009
• Last updated: June 24, 2011
• Start date: November 2009
• Est. completion date: August 2012

Study information

• Verified date: November 2009
• Source: Federico II University
• Contact: Serafino Fazio, MD
• Phone: +390817463737
• Email: fazio[@]unina.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise Tolerance
• Heart Failure

Intervention

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
• VVI at 40 bpm
ICDs will be programmed in VVI mode at 40 bpm

Locations

Country	Name	City	State
Italy	Federico II University - Department of Internal Medicine	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Oxygen consumption on cardiopulmonary exercise testing		1 month	Yes
Secondary	Peak Heart Rate on Cardiopulmonary exercise testing		1 month	No
Secondary	Quality of life as assessed by Minnesota Living with Heart Failure and SF-36 Questionnaires		1 month	No
Secondary	Heart Rate Variability on Holter Monitoring		1 month	No
Secondary	Acute Change in Peak Oxygen Consumption after reprogrammation		1 hour	No
Secondary	NT-proBNP levels		1 Month	No