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

NCT03160625 | Withdrawn FDA Device

• 1 other identifier: RESPOND-HF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Exercise time

  Exercise time on a treadmill guided by respiratory exchange ratio (RER) during cardiopulmonary exercise test (CPET).

  18 Weeks

Secondary Outcomes (12)

• Peak VO2

  18 Weeks

• Peak metabolic equivalents (METs)

  18 Weeks

• Peak respiratory exchange ratio (RER)

  18 Weeks

• VE/VO2 slope

  18 Weeks

• VO2 at Ventilator Anaerobic Threshold (VAT)

  18 Weeks

Study Arms (2)

Rate Adaptive Pacing ON

ACTIVE COMPARATOR

The Rate Adaptive Pacing (RAP) feature in the Medtronic implantable pulse generator (IPG) will be programmed to level 4 (More Active Lifestyle) with ADL rate of 95 bpm or higher, and Upper sensor rate that is subject's age predicted maximum heart rate. The age predicted maximum heart rate (APMHR) will be computed as: APHMR = 220 - age

Device: Rate Adaptive Pacing

Rate Adaptive Pacing OFF

ACTIVE COMPARATOR

The Rate Adaptive Pacing (RAP) feature in the Medtronic implantable pulse generator (IPG) will be turned off for this arm of the study.

Device: Rate Adaptive Pacing

Interventions

Rate Adaptive Pacing DEVICE

Rate Adaptive Pacing varies the pacing rate in response to the patient's physical motion as detected by an activity sensor.

Rate Adaptive Pacing OFF; Rate Adaptive Pacing ON

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (5)

Mayo Clinic (Rochester MN)

Rochester, Minnesota, 55000, United States

Location

Mid America Heart Institute (MAHI)

Kansas City, Missouri, 64111, United States

Location

Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Study Officials

• Aida Cicic, MD

  Medtronic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects' principal investigator and study team will be blinded to the randomization assignment. However clinical site personnel performing the device programming will not be blinded. Site personnel performing the CPET and 6-min hall walk assessments will be blinded to the randomization assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To assess whether rate adaptive pacing provides benefit to HFpEF patients, a pool of up to 60 qualifying subjects with pre-existing pacemaker and established diagnosis of HFpEF who demonstrate chronotropic incompetence (CI) with RAP turned off will be enrolled. Subjects who meet CI criterion during Visit 2 will be randomized. Subjects' principal investigator and study team will be blinded to the randomization assignment. However clinical site personnel performing the device programming will not be blinded. Site personnel performing the CPET and 6-min hall walk assessments will be blinded to the randomization assignment. Crossover of study subjects will occur during Visit 3, which will occur 12 weeks after subject enrollment. Subjects who were randomized with RAP ON first will have the device programmed to RAP OFF and conversely, subjects who were randomized to RAP OFF first will have the device programmed to RAP ON.

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: May 19, 2017
• Study Start: July 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: May 31, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)