Chronotropic Incompetence, Heart Failure, ICD
Conditions
Keywords
Chronotropic Incompetence, Rate Adaptive Pacing, Minute Ventilation Sensor, Primary Prevention ICD Therapy, Implantable Cardioverter Defibrillator, Heart Failure, Exercise Intolerance
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.
Interventions
DEVICEAAIR pacing
Rate adaptive pacing using a MV sensor.
DEVICEDDI-pacing
Rate adaptive pacing OFF
Sponsors
UMC Utrecht
Maasstad Hospital
Northwest Clinics Alkmaar
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The pacing mode set by the pacemaker technician will not be disclosed to either patients or the study physician.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of quality of life | 3 months after changing the pacing mode | Measured with the Minnesota Living with Heart Failure Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of functional capacity | 3 months after changing the pacing mode | Measured with a six-minute walk test |
| Reversibility of chronotropic incompetence | 3 months after changing the pacing mode | A comparison of the modified HeartRateScore with and without rate adaptive pacing. |
| Clinical status | 3 months after changing the pacing mode | Measured with NYHA class assessment and number of hospitalizations for heart failure. |
| Daily activity level | 3 months after changing the pacing mode | Measured with the device's accelerometer |
Countries
Netherlands
Contacts
Primary ContactCornelis P Allaart, MD, PhD
Backup ContactAnne-Lotte CJ van der Lingen, MD
Outcome results
None listed