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.
The RESPOND-HF is a prospective, multi-center, investigational, pilot study with cross-over design. Patients with existing pacemakers who have been diagnosed with HFpEF and meet study inclusion/exclusion criteria will be included in the study. The study is expected to be conducted at up to 5 centers in the United States and up to 300 patients will be consented to enroll up to 100 qualifying patients . Up to 60 patients meeting chronotropic incompetence (CI) criterion will be enrolled. The study will be conducted in subjects who have previously (≥ 30 days) been implanted with Medtronic, dual chamber pacemaker (IPG) device with rate adaptive pacing (RAP) feature. Additionally, up to 40 patients who do not meet CI criterion will be enrolled to collect ambulatory activity and heart rate data using AVIVO/SEEQ patch. These patients will be followed for only 1 week. It is estimated that subject enrollment will take approximately 12 to 18 months, with a study follow-up of 18 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Rate Adaptive Pacing varies the pacing rate in response to the patient's physical motion as detected by an activity sensor.
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
Exercise time
Exercise time on a treadmill guided by respiratory exchange ratio (RER) during cardiopulmonary exercise test (CPET).
Time frame: 18 Weeks
Peak VO2
Maximum rate of oxygen consumption during treadmill testing
Time frame: 18 Weeks
Peak metabolic equivalents (METs)
Ratio of the rate of energy expended during treadmill testing to the rate of energy expended at rest
Time frame: 18 Weeks
Peak respiratory exchange ratio (RER)
Maximum ratio between the amount of carbon dioxide (CO2) produced and oxygen (O2) used during treadmill testing
Time frame: 18 Weeks
VE/VO2 slope
Minute ventilation oxygen consumption relationship
Time frame: 18 Weeks
VO2 at Ventilator Anaerobic Threshold (VAT)
Rate of oxygen consumption at VAT during treadmill testing
Time frame: 18 Weeks
VCO2 at Ventilator Anaerobic Threshold (VAT)
Rate of carbon dioxide production at VAT during treadmill testing
Time frame: 18 Weeks
KCCQ
Subject's quality of life measure using KCCQ
Time frame: 18 Weeks
6 Minute Hall Walk
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Lancaster General Hospital
Lancaster, Pennsylvania, United States
Subject's activity of daily living as measure by 6 minute hall walk
Time frame: 18 Weeks
Daily Activity
Activity data collected by the implantable device and wearable sensor (SEEQ/AVIVO patch)
Time frame: 18 Weeks
Global Patient Health Assessment
Global patient health status using 0-100 visual analog scale
Time frame: 18 Weeks
NT-proBNP
N-terminus pro Brain Natriuretic Peptide
Time frame: 18 Weeks
Correlation between activity and HR
Correlation between activity and heart rate
Time frame: 18 Weeks