Heart Failure Clinical Trial
— ADAPTIONOfficial title:
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.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | December 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | VU university medical center | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
VU University Medical Center | Maasstad Hospital, Northwest Clinics Alkmaar, UMC Utrecht |
Netherlands,
Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of quality of life | Measured with the Minnesota Living with Heart Failure Questionnaire | 3 months after changing the pacing mode | |
Secondary | Improvement of functional capacity | Measured with a six-minute walk test | 3 months after changing the pacing mode | |
Secondary | Reversibility of chronotropic incompetence | A comparison of the modified HeartRateScore with and without rate adaptive pacing. | 3 months after changing the pacing mode | |
Secondary | Clinical status | Measured with NYHA class assessment and number of hospitalizations for heart failure. | 3 months after changing the pacing mode | |
Secondary | Daily activity level | Measured with the device's accelerometer | 3 months after changing the pacing mode |
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