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

NCT01016431 | Unknown Phase 4

• 1 other identifier: CHRON-INC-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Exercise Tolerance

Keywords

cardiac pacing; heart failure; oxygen consumption; ventricular dysfunction; left, exercise tolerance; chronotropic incompetence; pacemaker programming

Outcome Measures

Primary Outcomes (1)

• Peak Oxygen consumption on cardiopulmonary exercise testing

  1 month

Secondary Outcomes (5)

• Peak Heart Rate on Cardiopulmonary exercise testing

  1 month

• Quality of life as assessed by Minnesota Living with Heart Failure and SF-36 Questionnaires

  1 month

• Heart Rate Variability on Holter Monitoring

  1 month

• Acute Change in Peak Oxygen Consumption after reprogrammation

  1 hour

• NT-proBNP levels

  1 Month

Study Arms (2)

Rate adaptive

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

ICDs will be programmed in the usual VVI backup pacing mode at 40 bpm

Other: VVI at 40 bpm

Interventions

Rate-adaptive pacemaker programming OTHER

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

Rate adaptive

VVI at 40 bpm OTHER

ICDs will be programmed in VVI mode at 40 bpm

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University - Department of Internal Medicine

Naples, 80100, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Serafino Fazio, MD

CONTACT

+390817463737; fazio@unina.it

Guido Carlomagno, MD

CONTACT

guido.carlomagno@yahoo.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 27, 2011

Record last verified: 2009-11

Locations

IT (1)