NCT02145351

Brief Summary

Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 5, 2023

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

8.1 years

First QC Date

May 20, 2014

Results QC Date

March 3, 2023

Last Update Submit

March 31, 2023

Conditions

Heart Failure With a Preserved Ejection FractionHeart Failure, DiastolicChronotropic Incompetence

Keywords

HFpEFHeart failureHeart failure with preserved ejection fractionChronotropic incompetence

Outcome Measures

Primary Outcomes (1)

  • Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)

    Maximal effort cardiopulmonary exercise testing was performed on a treadmill after 4 weeks of pacing-on and after 4 weeks of pacing-off to measure volumes of oxygen consumed (VO2). Change in VO2 at anaerobic threshold (VO2,AT) determined by the V-Slope method as the point of disproportionate rise in VCO2 relative to VO2 as measured in ml/kg/min.

    baseline, after 4 weeks of treatment

Secondary Outcomes (4)

  • Peak Aerobic Capacity (Peak VO2)

    4 weeks after pacemaker activation

  • Ventilatory Efficiency (VE/VCO2)

    4 weeks

  • Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)

    baseline, after 4 weeks of treatment

  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

    baseline, after 4 weeks of treatment

Other Outcomes (1)

  • Mean Peak Heart Rate (HR)

    4 weeks

Study Arms (2)

Pacing off first, then pacing on

ACTIVE COMPARATOR

No-pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing on for an additional 4 weeks.

Device: Rate adaptive atrial pacing using a dual-chamber pacemakerDevice: Pacemaker system will be implanted but set to Pacing Off.

Pacing on first, then pacing off

EXPERIMENTAL

Pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing off for an additional 4 weeks

Device: Rate adaptive atrial pacing using a dual-chamber pacemakerDevice: Pacemaker system will be implanted but set to Pacing Off.

Interventions

Rate adaptive atrial pacing using a dual-chamber pacemakerDEVICE

The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086.

Also known as: Medtronic Azure XT DR MRI pacemaker model W1DR01, Medtronic CapSureFix MRI model 5086
Pacing off first, then pacing onPacing on first, then pacing off
Pacemaker system will be implanted but set to Pacing Off.DEVICE

The identical pacing system will be implanted, but will be set to Pacing Off.

Also known as: Medtronic Azure XT DR MRI model W1DR01, Medtronic CapSureFix MRI model 5086
Pacing off first, then pacing onPacing on first, then pacing off

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.
  • Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
  • At least one of the following: Hospitalization for decompensated HF, Acute treatment for HF with intravenous loop diuretic or hemofiltration, Chronic treatment with a loop diuretic for control of HF symptoms + left atrial enlargement on echocardiography or E/e' ratio (≥14 average, ≥15 septal ) on echocardiography, Resting PCWP \>15 mm Hg or LV end-diastolic pressure \>18 mmHg at catheterization for dyspnea and/or exercise PCWP/LV end-diastolic pressure \>25 mmHg, or Elevated NT-proBNP level (≥300 pg/ml )
  • Left ventricular EF ≥40% within 12 months with clinical stability
  • Stable cardiac medical therapy for ≥30 days
  • Sinus rhythm
  • Chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (HRR) \<0.80 or \<0.62 if on beta blockers
  • Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.

You may not qualify if:

  • Inability to exercise, or non-cardiac condition that precludes exercise testing
  • Any contraindication to a pacemaker system
  • Non-cardiac condition limiting life expectancy to less than one year
  • Significant left sided structural valve disease (\>mild stenosis, \>moderate regurgitation)
  • Hypertrophic cardiomyopathy
  • Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
  • Pericardial disease
  • Non-group 2 pulmonary arterial hypertension
  • Chronic stable exertional angina
  • Acute coronary syndrome or revascularization within 60 days
  • Other clinically important causes of dyspnea
  • Atrial fibrillation
  • PR interval \>210 msec
  • Resting heart rate (HR) \> 100 bpm
  • A history of reduced ejection fraction (EF\<40%)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Reddy YNV, Koepp KE, Carter R, Win S, Jain CC, Olson TP, Johnson BD, Rea R, Redfield MM, Borlaug BA. Rate-Adaptive Atrial Pacing for Heart Failure With Preserved Ejection Fraction: The RAPID-HF Randomized Clinical Trial. JAMA. 2023 Mar 14;329(10):801-809. doi: 10.1001/jama.2023.0675.

    PMID: 36871285DERIVED

Related Links

MeSH Terms

Conditions

Heart Failure, DiastolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Barry A. Borlaug, M.D.
Organization
Mayo Clinic
Borlaug.Barry@mayo.edu
507-255-4152

Study Officials

  • Barry Borlaug, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

April 7, 2014

Primary Completion

May 9, 2022

Study Completion

May 9, 2022

Last Updated

April 5, 2023

Results First Posted

April 5, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)