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Pacemaker

Pacing on first, then pacing off for Heart Failure (RAPID-HF Trial)

N/A
Waitlist Available
Led By Barry Borlaug, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

RAPID-HF Trial Summary

This trial will study the effects of restoring a normal heart rate response during exercise and daily activity in patients with heart failure and preserved ejection fraction (HFpEF) who also have chronotropic incompetence (CI).

Eligible Conditions
  • Heart Failure
  • Chronotropic Incompetence

RAPID-HF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)
Secondary outcome measures
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Peak Aerobic Capacity (Peak VO2)
+1 more
Other outcome measures
Mean Peak Heart Rate (HR)

RAPID-HF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pacing on first, then pacing offExperimental Treatment2 Interventions
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
Group II: Pacing off first, then pacing onActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rate adaptive atrial pacing using a dual-chamber pacemaker
2014
N/A
~40
Pacemaker system will be implanted but set to Pacing Off.
2014
N/A
~40

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,208 Previous Clinical Trials
3,767,018 Total Patients Enrolled
72 Trials studying Heart Failure
1,021,996 Patients Enrolled for Heart Failure
MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,633 Total Patients Enrolled
90 Trials studying Heart Failure
90,762 Patients Enrolled for Heart Failure
Barry Borlaug, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus, Mayo Clinic Rochester
University Of Wisconsin Medical Sch (Medical School)
Johns Hopkins University School Medicine (Residency)
9 Previous Clinical Trials
1,427 Total Patients Enrolled
6 Trials studying Heart Failure
1,047 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Barry Borlaug 2014. "Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02145351.
~3 spots leftby Apr 2025
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