Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure With a Preserved Ejection Fraction; Heart Failure, Diastolic; Chronotropic Incompetence
• Interventions: Device: Rate adaptive atrial pacing using a dual-chamber pacemaker; Device: Pacemaker system will be implanted but set to Pacing Off.

• Registration Number: NCT02145351
• Lead Sponsor: Mayo Clinic

Brief Summary

Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-07
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-22
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Status Verified: 2023-03
• Results First Submitted: 2023-03-03
• Results First Submitted QC: 2023-03-31
• Last Update Submitted: 2023-03-31
• Results First Posted: 2023-04-05
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pacing on first, then pacing off	Rate adaptive atrial pacing using a dual-chamber pacemaker	Pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing off for an additional 4 weeks
Pacing off first, then pacing on	Rate adaptive atrial pacing using a dual-chamber pacemaker	No-pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing on for an additional 4 weeks.
Pacing off first, then pacing on	Pacemaker system will be implanted but set to Pacing Off.	No-pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing on for an additional 4 weeks.
Pacing on first, then pacing off	Pacemaker system will be implanted but set to Pacing Off.	Pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing off for an additional 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)	baseline, after 4 weeks of treatment	Maximal effort cardiopulmonary exercise testing was performed on a treadmill after 4 weeks of pacing-on and after 4 weeks of pacing-off to measure volumes of oxygen consumed (VO2). Change in VO2 at anaerobic threshold (VO2,AT) determined by the V-Slope method as the point of disproportionate rise in VCO2 relative to VO2 as measured in ml/kg/min.

Secondary Outcome Measures

Name	Time	Method
Ventilatory Efficiency (VE/VCO2)	4 weeks	Determined as the nadir of VE/VCO2 ratio during exercise. Maximal effort cardiopulmonary exercise testing was performed on a treadmill after 4 weeks of pacing-on and after 4 weeks of pacing-off to measure volumes of oxygen consumed (VO2).
Peak Aerobic Capacity (Peak VO2)	4 weeks after pacemaker activation	Determined as the mean of values obtained over the final 30 seconds of exercise. Maximal effort cardiopulmonary exercise testing was performed on a treadmill after 4 weeks of pacing-on and after 4 weeks of pacing-off to measure volumes of oxygen consumed (VO2). As measured in ml/kg/min.
Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)	baseline, after 4 weeks of treatment	Change in plasma NT-proBNP as measured in pg/mL. Natriuretic peptides are substances made by the heart. A main type of these substances is NT-proBNP. Elevated levels can mean the heart isn't pumping as much blood the body needs.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	baseline, after 4 weeks of treatment	Change from baseline in KCCQ-overall summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ- overall summary score was average of domains- physical limitation, total symptoms (average of symptom frequency and symptom burden), quality of life, and social limitation, and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States