Evaluation of Rate Adaptive Pacing on Chronotropic Response in Preserved Ejection Fraction HF

Overview

  • Study type

    Interventional
  • Study IDs

  • 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.
  • Site IRB
    • Rochester, Minnesota: 17-004790
    NCT ID: NCT03160625
    Sponsor Protocol Number: 056-F275

About this study

RESPOND-HF is a prospective, multi-center, non-significant risk pilot study with cross-over design. The purpose of the study is to investigate if rate adaptive pacing has the potential to provide benefit to HF patients with preserved ejection fraction, referred to as HFpEF patients. Findings from this pilot study may be used to guide subsequent efforts to design and conduct a prospective, randomized, multi-center pivotal trial powered to show improvement in patient outcomes.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years or legal age to provide informed consent
  • Willing and be able to provide informed consent
  • Previous clinical diagnosis of HF and exhibits HF signs and symptoms consistent with NYHA II or III (or class B or C)
  • Chronic Rx for heart failure with loop diuretic or a mineralocorticoid receptor antagonist (MRA)
  • LVEF ≥ 45% within previous 12 months. Acceptable methods include echo, ventriculogram (angiography or nuclear), nuclear stress test. If patient has a prior history of significant left ventricular systolic dysfunction defined as EF < 0.40, patient must have a HF event within previous 12 months defined as:
    • Hospitalization for decompensated HF
    • Unscheduled treatment for HF with intravenous loop diuretic or hemofiltration
  • On stable HF medical therapy for previous 30 days. Dose changes of ACEI / ARB and beta blockers of less than 50% increase or decrease are acceptable for stability
  • Treadmill exercise time using modified Naughton protocol of greater than 3 min and less than 15 min for men and 14 for women
  • Medtronic dual chamber pacemaker implanted for ≥ 30 days
  • Sinus rhythm at rest

Exclusion Criteria:

  • Women who are pregnant or plan to become pregnant
  • Life expectancy less than 1 year
  • Enrollment in any concurrent study that could potentially be confounding
  • Orthopedic, neuromuscular or any other condition limiting exercise testing
  • Unstable angina or MI or have undergone CABG/PTCA within previous 60 days
  • A candidate for CABG/PTCA at the time of informed consent
  • Use of inotrope therapy on a regular basis (e.g. daily, weekly etc.)
  • Severe and/or poorly controlled major active comorbidity, including (but not limited to):
    • Diabetes: Hb1AC > 9.5
    • Severe COPD: e.g. end stage emphysema managed using 2 or more inhalers and/or using home oxygen
    • Severe pulmonary disease limiting functional capacity
    • Hypertension: SBP > 160 mmHg at time of screening
    • Cancer: Ongoing therapy or therapy within previous 3 months
    • Severe valvular disease
    • Renal impairment with serum creatinine > 3 mg/dL
    • Anemia with hemoglobin < 8 g/dL or major bleeding event within the past 60 days
  • Primary diagnosis of pulmonary arterial hypertension with ongoing severe pulmonary hypertension and treatment
  • Known familial hypertrophic cardiomyopathy or hypertrophic obstructive cardiomyopathy
  • Known restrictive cardiomyopathy or systemic illness known to be associated with infiltrative myocardial disease (e.g. amyloidosis, sarcoidosis, hemochromatosis)
  • Pericardial restriction or hemodynamically significant pericardial effusion
  • Patients expected to undergo device or lead replacement within study follow-up duration
  • Allergies to hydrogel in SEEQ/AVIVO patch
  • Patients who are expected to be ventricular paced over 40% of the time
  • Long standing persistent AF Or Ongoing episode of persistent AF

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Open for enrollment

Contact information:

Geraldine Hider R.N.

Hider.Geraldine@mayo.edu

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CLS-20346518

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