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Completed

NCT Number: NCT02145351

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

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).

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Key information

Conditions

Heart Failure With a Preserved Ejection Fraction Cardiovascular Diseases Chronotropic Incompetence Heart Diseases Heart Failure Heart Failure, Diastolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.
  • Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
  • At least one of the following: Hospitalization for decompensated HF, Acute treatment for HF with intravenous loop diuretic or hemofiltration, Chronic treatment with a loop diuretic for control of HF symptoms + left atrial enlargement on echocardiography or E/e' ratio (≥14 average, ≥15 septal ) on echocardiography, Resting PCWP >15 mm Hg or LV end-diastolic pressure >18 mmHg at catheterization for dyspnea and/or exercise PCWP/LV end-diastolic pressure >25 mmHg, or Elevated NT-proBNP level (≥300 pg/ml )
  • Left ventricular EF ≥40% within 12 months with clinical stability
  • Stable cardiac medical therapy for ≥30 days
  • Sinus rhythm
  • Chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (HRR) <0.80 or <0.62 if on beta blockers
  • Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.

Exclusion criteria

  • Inability to exercise, or non-cardiac condition that precludes exercise testing
  • Any contraindication to a pacemaker system
  • Non-cardiac condition limiting life expectancy to less than one year
  • Significant left sided structural valve disease (>mild stenosis, >moderate regurgitation)
  • Hypertrophic cardiomyopathy
  • Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
  • Pericardial disease
  • Non-group 2 pulmonary arterial hypertension
  • Chronic stable exertional angina
  • Acute coronary syndrome or revascularization within 60 days
  • Other clinically important causes of dyspnea
  • Atrial fibrillation
  • PR interval >210 msec
  • Resting heart rate (HR) > 100 bpm
  • A history of reduced ejection fraction (EF<40%)
  • Advanced chronic kidney disease (GFR < 20 ml/min/1.73m2 by modified MDRD equation)
  • Women of child bearing potential without negative pregnancy test and effective contraception
  • Severe anemia (Hemoglobin <10 g/dL)
  • Severe hepatic disease
  • Complex congenital heart disease
  • Listed for cardiac transplantation
  • Other class I indications for pacing

Treatment and study plan

Rate adaptive atrial pacing using a dual-chamber pacemaker

Device

The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086.

Other names: Medtronic Azure XT DR MRI pacemaker model W1DR01, Medtronic CapSureFix MRI model 5086

Pacemaker system will be implanted but set to Pacing Off.

Device

The identical pacing system will be implanted, but will be set to Pacing Off.

Other names: Medtronic Azure XT DR MRI model W1DR01, Medtronic CapSureFix MRI model 5086

Primary outcomes

  1. Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)

    Time frame: 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 outcomes

  1. Peak Aerobic Capacity (Peak VO2)

    Time frame: 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.

  2. Ventilatory Efficiency (VE/VCO2)

    Time frame: 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).

  3. Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)

    Time frame: 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.

  4. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

    Time frame: 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.

Other outcomes

  1. Mean Peak Heart Rate (HR)

    Time frame: 4 weeks

    Determined as the maximum heart rate . Heart rate (or pulse rate) is the frequency of the heartbeat measured by the number of contractions of the heart per minute (beats per minute, or bpm).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Medtronic

Registry information

Official study title

Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)

Acronym: RAPID-HF

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
May 22, 2014
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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