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

Primary Purpose

Heart Failure, Exercise Tolerance

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Rate-adaptive pacemaker programming
VVI at 40 bpm
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring cardiac pacing, heart failure, oxygen consumption, ventricular dysfunction, left, exercise tolerance, chronotropic incompetence, pacemaker programming

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federico II University - Department of Internal MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rate adaptive

Control

Arm Description

Patients will have their ICD programmed in a AAI-R mode, with peak atrial rate set at 85% of age-adjusted predicted maximal HR

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

Outcomes

Primary Outcome Measures

Peak Oxygen consumption on cardiopulmonary exercise testing

Secondary Outcome Measures

Peak Heart Rate on Cardiopulmonary exercise testing
Quality of life as assessed by Minnesota Living with Heart Failure and SF-36 Questionnaires
Heart Rate Variability on Holter Monitoring
Acute Change in Peak Oxygen Consumption after reprogrammation
NT-proBNP levels

Full Information

First Posted
November 18, 2009
Last Updated
June 24, 2011
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT01016431
Brief Title
Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence
Official Title
Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Exercise Tolerance
Keywords
cardiac pacing, heart failure, oxygen consumption, ventricular dysfunction, left, exercise tolerance, chronotropic incompetence, pacemaker programming

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rate adaptive
Arm Type
Experimental
Arm Description
Patients will have their ICD programmed in a AAI-R mode, with peak atrial rate set at 85% of age-adjusted predicted maximal HR
Arm Title
Control
Arm Type
Active Comparator
Arm Description
ICDs will be programmed in the usual VVI backup pacing mode at 40 bpm
Intervention Type
Other
Intervention Name(s)
Rate-adaptive pacemaker programming
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
VVI at 40 bpm
Intervention Description
ICDs will be programmed in VVI mode at 40 bpm
Primary Outcome Measure Information:
Title
Peak Oxygen consumption on cardiopulmonary exercise testing
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Peak Heart Rate on Cardiopulmonary exercise testing
Time Frame
1 month
Title
Quality of life as assessed by Minnesota Living with Heart Failure and SF-36 Questionnaires
Time Frame
1 month
Title
Heart Rate Variability on Holter Monitoring
Time Frame
1 month
Title
Acute Change in Peak Oxygen Consumption after reprogrammation
Time Frame
1 hour
Title
NT-proBNP levels
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serafino Fazio, MD
Phone
+390817463737
Email
fazio@unina.it
First Name & Middle Initial & Last Name or Official Title & Degree
Guido Carlomagno, MD
Email
guido.carlomagno@yahoo.it
Facility Information:
Facility Name
Federico II University - Department of Internal Medicine
City
Naples
ZIP/Postal Code
80100
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

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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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