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Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure (RAPID-HF)

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ClinicalTrials.gov Identifier: NCT02145351
Recruitment Status : Recruiting
First Posted : May 22, 2014
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Barry Borlaug, Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Heart Failure With a Preserved Ejection Fraction Heart Failure, Diastolic Chronotropic Incompetence Device: Rate adaptive atrial pacing using a dual-chamber pacemaker Device: Pacemaker system will be implanted but set to Pacing Off. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)
Actual Study Start Date : April 7, 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Pacing off
In this crossover study design, subjects will be randomized to pacing on or pacing off, and will switch to the opposite group midway through the study. They will be compared to themselves when pacing is on vs pacing off for endpoints of interest.
Device: Pacemaker system will be implanted but set to Pacing Off.
The identical pacing system will be implanted, but will be set to Pacing Off.
Other Names:
  • Medtronic Azure XT DR MRI model W1DR01
  • Medtronic CapSureFix MRI model 5086

Experimental: Pacing on
In this crossover study design, subjects will be randomized to pacing on or pacing off, and will switch to the opposite group midway through the study. They will be compared to themselves when pacing is on vs pacing off for endpoints of interest.
Device: Rate adaptive atrial pacing using a dual-chamber pacemaker
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.
Other Names:
  • Medtronic Azure XT DR MRI pacemaker model W1DR01
  • Medtronic CapSureFix MRI model 5086




Primary Outcome Measures :
  1. Oxygen consumption (VO2) at ventilatory anaerobic threshold (VAT) as measure of exercise capacity [ Time Frame: 4 weeks after pacemaker activation ]

Secondary Outcome Measures :
  1. Daily activity assessed by average daily minutes active from pacemaker accelerometry [ Time Frame: 4 weeks after pacemaker activation ]

Other Outcome Measures:
  1. Scores on Kansas City Cardiomyopathy questionnaire (KCCQ) [ Time Frame: 4 weeks ]
  2. NT-proBNP Levels [ Time Frame: 4 weeks ]
  3. Six minute walk test distance [ Time Frame: 4 weeks ]
  4. Self-reported symptoms of breathlessness and fatigue during cardiopulmonary exercise testing (Borg scores) [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Age >18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.
  2. Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
  3. 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 )
  4. Left ventricular EF ≥40% within 12 months with clinical stability
  5. Stable cardiac medical therapy for ≥30 days
  6. Sinus rhythm
  7. 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
  8. Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.

Exclusion Criteria

  1. Inability to exercise, or non-cardiac condition that precludes exercise testing
  2. Any contraindication to a pacemaker system
  3. Non-cardiac condition limiting life expectancy to less than one year
  4. Significant left sided structural valve disease (>mild stenosis, >moderate regurgitation)
  5. Hypertrophic cardiomyopathy
  6. Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
  7. Pericardial disease
  8. Non-group 2 pulmonary arterial hypertension
  9. Chronic stable exertional angina
  10. Acute coronary syndrome or revascularization within 60 days
  11. Other clinically important causes of dyspnea
  12. Atrial fibrillation
  13. PR interval >210 msec
  14. Resting heart rate (HR) > 100 bpm
  15. A history of reduced ejection fraction (EF<40%)
  16. Advanced chronic kidney disease (GFR < 20 ml/min/1.73m2 by modified MDRD equation)
  17. Women of child bearing potential without negative pregnancy test and effective contraception
  18. Severe anemia (Hemoglobin <10 g/dL)
  19. Severe hepatic disease
  20. Complex congenital heart disease
  21. Listed for cardiac transplantation
  22. Other class I indications for pacing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145351


Contacts
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Contact: Laura Verbout-Kveene, CRC 507-255-2200 Kveene.Laura@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Laura Verbout-Kveene    507-255-2200    Kveene.Laura@mayo.edu   
Principal Investigator: Barry Borlaug         
Sub-Investigator: Margaret Redfield         
Sponsors and Collaborators
Mayo Clinic
Medtronic
Investigators
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Principal Investigator: Barry Borlaug, MD Mayo Clinic
Additional Information:
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Responsible Party: Barry Borlaug, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02145351    
Other Study ID Numbers: 13-008306
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Barry Borlaug, Mayo Clinic:
HFpEF
Heart failure
Heart failure with preserved ejection fraction
Chronotropic incompetence
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases