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

Withdrawn before enrolling · Not applicable

Conditions studied: Heart Failure With Preserved Ejection Fraction

In brief

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.

Key facts

Study ID

NCT03160625

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

0

Starts

2017-07-01

Expected to finish

2018-05-31

Last updated by the study team

2018-04-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic (Rochester MN) — Rochester, Minnesota, United States
• Mid America Heart Institute (MAHI) — Kansas City, Missouri, United States
• Lindner Research Center — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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