Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients with Heart Failure
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 13-008306
NCT ID: NCT02145351
Sponsor Protocol Number: 13-008306
About this study
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).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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
- Left ventricular EF ≥50% 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
- Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months. Peak VO2 ≤60% age/sex-adjusted normal value + peak respiratory exchange ratio (RER) ≥1.05 One of the following: NT-proBNP ≥400 pg/mL or NT-proBNP <400 pg/mL, with rest PCWP >20 mmHg and/or >25 mmHg with exercise
- 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<50%)
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.