Rate Adaptive Atrial Pacing in Heart Failure (ADAPTION)

Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; ICD; Chronotropic Incompetence
• Intervention / Treatment: Device: AAIR pacing; Device: DDI-pacing

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1081HV
    • Recruiting
    • VU University Medical Center
    • Contact: Anne-Lotte van der Lingen, MD; Phone Number: +31204443272; Email: a.vanderlingen@vumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rate Adaptive Pacing ON; AAIR pacing using a MV sensor	Device: AAIR pacing; Rate adaptive pacing using a MV sensor.
Placebo Comparator: Rate Adaptive Pacing OFF; DDI-pacing	Device: DDI-pacing; Rate adaptive pacing OFF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of quality of life	Measured with the Minnesota Living with Heart Failure Questionnaire	3 months after changing the pacing mode

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of functional capacity	Measured with a six-minute walk test	3 months after changing the pacing mode
Reversibility of chronotropic incompetence	A comparison of the modified HeartRateScore with and without rate adaptive pacing.	3 months after changing the pacing mode
Clinical status	Measured with NYHA class assessment and number of hospitalizations for heart failure.	3 months after changing the pacing mode
Daily activity level	Measured with the device's accelerometer	3 months after changing the pacing mode

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: UMC Utrecht; Maasstad Hospital; Northwest Clinics Alkmaar
• Investigators: Principal Investigator: Cornelis P Allaart, MD, PhD, Amsterdam UMC, location VUmc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Heart Failure; Implantable Cardioverter Defibrillator; Exercise Intolerance; Chronotropic Incompetence; Rate Adaptive Pacing; Minute Ventilation Sensor; Primary Prevention ICD Therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ISROTH20232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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