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Heart Failure With Preserved Ejection FractionRESPOND-HFNCT03160625

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

A study testing Rate Adaptive Pacing in people with Heart Failure With Preserved Ejection Fraction, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Rate Adaptive Pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
5 sitesUnited States
Study dates
1 Jul 2017to 31 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Lindner Research Center

    Cincinnati, Ohio, 45219

  • Ohio State University

    Columbus, Ohio, 43210

  • Mid America Heart Institute (MAHI)

    Kansas City, Missouri, 64111

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Mayo Clinic (Rochester MN)

    Rochester, Minnesota, 55000

Other trials in United States

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.

Read the detailed description

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.

Being tested
Rate Adaptive Pacing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rate Adaptive PacingDevice

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

Study groups in NCT03160625
Study groupRoleWhat they receive
Rate Adaptive Pacing ONActive comparatorThe 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
Receives: Device: Rate Adaptive Pacing
Rate Adaptive Pacing OFFActive comparatorThe Rate Adaptive Pacing (RAP) feature in the Medtronic implantable pulse generator (IPG) will be turned off for this arm of the study.
Receives: Device: Rate Adaptive Pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise time

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

    Measured: 18 Weeks

Secondary outcomes (12)

  1. Peak VO2

    Maximum rate of oxygen consumption during treadmill testing

    Measured: 18 Weeks

  2. Peak metabolic equivalents (METs)

    Ratio of the rate of energy expended during treadmill testing to the rate of energy expended at rest

    Measured: 18 Weeks

  3. Peak respiratory exchange ratio (RER)

    Maximum ratio between the amount of carbon dioxide (CO2) produced and oxygen (O2) used during treadmill testing

    Measured: 18 Weeks

  4. VE/VO2 slope

    Minute ventilation oxygen consumption relationship

    Measured: 18 Weeks

  5. VO2 at Ventilator Anaerobic Threshold (VAT)

    Rate of oxygen consumption at VAT during treadmill testing

    Measured: 18 Weeks

  6. VCO2 at Ventilator Anaerobic Threshold (VAT)

    Rate of carbon dioxide production at VAT during treadmill testing

    Measured: 18 Weeks

  7. KCCQ

    Subject's quality of life measure using KCCQ

    Measured: 18 Weeks

  8. 6 Minute Hall Walk

    Subject's activity of daily living as measure by 6 minute hall walk

    Measured: 18 Weeks

  9. Daily Activity

    Activity data collected by the implantable device and wearable sensor (SEEQ/AVIVO patch)

    Measured: 18 Weeks

  10. Global Patient Health Assessment

    Global patient health status using 0-100 visual analog scale

    Measured: 18 Weeks

  11. NT-proBNP

    N-terminus pro Brain Natriuretic Peptide

    Measured: 18 Weeks

  12. Correlation between activity and HR

    Correlation between activity and heart rate

    Measured: 18 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2017
  2. Study start1 Jul 2017 (estimated)
  3. Primary completion30 Apr 2018 (estimated)
  4. Study completion31 May 2018 (estimated)

Why it stopped: Lack of eligible patient.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03160625
Sponsor's protocol ID
RESPOND-HF
Acronym
RESPOND-HF
Status last verified
Apr 2018
First submitted
22 Mar 2017
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Rate Adaptive Pacing in people with Heart Failure With Preserved Ejection Fraction, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise time (time frame: 18 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03160625.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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