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Rate Adaptive Atrial Pacing in Heart Failure (ADAPTION)

Primary Purpose

Chronotropic Incompetence, Heart Failure, ICD

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
AAIR pacing
DDI-pacing
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronotropic Incompetence focused on measuring Chronotropic Incompetence, Rate Adaptive Pacing, Minute Ventilation Sensor, Primary Prevention ICD Therapy, Implantable Cardioverter Defibrillator, Heart Failure, Exercise Intolerance

Eligibility Criteria

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

Inclusion Criteria:

  1. Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS)
  2. Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor
  3. Symptomatic congestive heart failure (NYHA class II-III)
  4. Left ventricular systolic dysfunction (LVEF <35%)
  5. Optimal medical therapy
  6. Sinus rhythm
  7. Subjects should be able to perform normal daily activities

Exclusion Criteria:

  1. Age <18 or incapacitated adult
  2. Documented atrial fibrillation in the last 3 months prior to inclusion
  3. Indication for pacing (SSS, AV conduction abnormalities requiring pacing)
  4. Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator
  5. Patients who are unable to tolerate increased pacing rates
  6. Indication for cardiac resynchronization therapy

Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion

Sites / Locations

  • VU university medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rate Adaptive Pacing ON

Rate Adaptive Pacing OFF

Arm Description

AAIR pacing using a MV sensor

DDI-pacing

Outcomes

Primary Outcome Measures

Improvement of quality of life
Measured with the Minnesota Living with Heart Failure Questionnaire

Secondary Outcome Measures

Improvement of functional capacity
Measured with a six-minute walk test
Reversibility of chronotropic incompetence
A comparison of the modified HeartRateScore with and without rate adaptive pacing.
Clinical status
Measured with NYHA class assessment and number of hospitalizations for heart failure.
Daily activity level
Measured with the device's accelerometer

Full Information

First Posted
July 10, 2017
Last Updated
August 1, 2017
Sponsor
Amsterdam UMC, location VUmc
Collaborators
UMC Utrecht, Maasstad Hospital, Northwest Clinics Alkmaar
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1. Study Identification

Unique Protocol Identification Number
NCT03235843
Brief Title
Rate Adaptive Atrial Pacing in Heart Failure
Acronym
ADAPTION
Official Title
Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
UMC Utrecht, Maasstad Hospital, Northwest Clinics Alkmaar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting. Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with chronotropic incompetence. Methods: heart failure patients (left ventricular ejection fraction ≤35% & New York Heart Assessment II or III) who were implanted with a 2-chamber implantable cardioverter defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3 months the pacing mode will be switched to the opposite mode.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronotropic Incompetence, Heart Failure, ICD
Keywords
Chronotropic Incompetence, Rate Adaptive Pacing, Minute Ventilation Sensor, Primary Prevention ICD Therapy, Implantable Cardioverter Defibrillator, Heart Failure, Exercise Intolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients enter a double blind randomized cross-over pilot study and will be randomized in a 1:1 fashion to either rate responsive (MV sensor only) function on or off. After 3 months the pacing mode will be switched to the opposite mode.
Masking
ParticipantInvestigator
Masking Description
The pacing mode set by the pacemaker technician will not be disclosed to either patients or the study physician.
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rate Adaptive Pacing ON
Arm Type
Active Comparator
Arm Description
AAIR pacing using a MV sensor
Arm Title
Rate Adaptive Pacing OFF
Arm Type
Placebo Comparator
Arm Description
DDI-pacing
Intervention Type
Device
Intervention Name(s)
AAIR pacing
Intervention Description
Rate adaptive pacing using a MV sensor.
Intervention Type
Device
Intervention Name(s)
DDI-pacing
Intervention Description
Rate adaptive pacing OFF
Primary Outcome Measure Information:
Title
Improvement of quality of life
Description
Measured with the Minnesota Living with Heart Failure Questionnaire
Time Frame
3 months after changing the pacing mode
Secondary Outcome Measure Information:
Title
Improvement of functional capacity
Description
Measured with a six-minute walk test
Time Frame
3 months after changing the pacing mode
Title
Reversibility of chronotropic incompetence
Description
A comparison of the modified HeartRateScore with and without rate adaptive pacing.
Time Frame
3 months after changing the pacing mode
Title
Clinical status
Description
Measured with NYHA class assessment and number of hospitalizations for heart failure.
Time Frame
3 months after changing the pacing mode
Title
Daily activity level
Description
Measured with the device's accelerometer
Time Frame
3 months after changing the pacing mode

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS) Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor Symptomatic congestive heart failure (NYHA class II-III) Left ventricular systolic dysfunction (LVEF <35%) Optimal medical therapy Sinus rhythm Subjects should be able to perform normal daily activities Exclusion Criteria: Age <18 or incapacitated adult Documented atrial fibrillation in the last 3 months prior to inclusion Indication for pacing (SSS, AV conduction abnormalities requiring pacing) Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator Patients who are unable to tolerate increased pacing rates Indication for cardiac resynchronization therapy Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cornelis P Allaart, MD, PhD
Phone
+31 (0)20 4445043
Email
cp.allaart@vumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Lotte CJ van der Lingen, MD
Phone
+31 (0)20 4443272
Email
a.vanderlingen@vumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelis P Allaart, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU university medical center
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Lotte van der Lingen, MD
Phone
+31204443272
Email
a.vanderlingen@vumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21382903
Citation
Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. No abstract available.
Results Reference
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Rate Adaptive Atrial Pacing in Heart Failure

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