Clinical trial NCT03235843: Rate Adaptive Atrial Pacing in Heart Failure
Official title: Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Maasstad Hospital
name: Northwest Clinics Alkmaar
First posted: 2017-08-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement of quality of life
timeFrame: 3 months after changing the pacing mode
Secondary outcomes:
measure: Improvement of functional capacity
timeFrame: 3 months after changing the pacing mode
measure: Reversibility of chronotropic incompetence
timeFrame: 3 months after changing the pacing mode
measure: Clinical status
timeFrame: 3 months after changing the pacing mode
measure: Daily activity level
timeFrame: 3 months after changing the pacing mode
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU university medical center
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Cornelis P Allaart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.