A Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
Site IRB
- 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).
Participation eligibility
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age ≥ 18 years old.
- 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 an intravenous diuretic or hemofiltration;
- Chronic treatment with a diuretic for control of HF symptoms + left atrial enlargement or elevated 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;
- 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 exercise test, defined as heart rate reserve (HRR) < 0.80 or < 0.62 if on beta blockers:
- HRR = [observed peak HR – observed rest HR]/[predicted peak HR – observed rest HR];
- Predicted peak HR will be calculated using the formula (220-age).
- Meet both screening criteria on clinically-performed CPX within 12 months.
Exclusion Criteria:
- Discernable ventilatory anaerobic threshold on previous CPX study.
- 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 obstructive 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/1.73m^2 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.
Eligibility last updated 11/9/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Barry Borlaug, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available