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

Overview

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

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Additional contact information

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