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Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction (PACE HFpEF)

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ClinicalTrials.gov Identifier: NCT04546555
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : February 25, 2021
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Daniel L Lustgarten, University of Vermont

Tracking Information
First Submitted Date  ICMJE August 31, 2020
First Posted Date  ICMJE September 14, 2020
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE February 23, 2021
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • Change in composite Minnesota-Living-with-Heart-Failure-Questionnaire score [ Time Frame: At 1 month, 2 months, 3 months, 4 months and 5 months ]
    Total score can range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life
  • Percent change in NTproBNP [ Time Frame: At 1 month, 2 months, 3 months, 4 months and 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • Change in 6 minute walk test [ Time Frame: At 1 month, 2 months, 3 months, 4 months and 5 months ]
  • Incident AF [ Time Frame: At 1 month, 2 months, 3 months, 4 months and 5 months ]
  • Burden of AF [ Time Frame: At 1 month, 2 months, 3 months, 4 months and 5 months ]
  • Hemodynamic changes by Echo [ Time Frame: At 3 months and at 5 months ]
  • Change in left ventricular mass/volume ratio by cardiac MRI [ Time Frame: 5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 4, 2020)
  • Quantitative assessment of the risks of pacemaker implantation [ Time Frame: 1 month ]
    Incidence of pocket hematoma, pocket infection phrenic or diaphragmatic stimulation, lead endocarditis, lead dysfunction/dislocation, pneumothorax, hemopericardium, mortality
  • Doubling in baseline Troponin or NTproBNP [ Time Frame: At 1 month, 2 months, 3 months, 4 months and 5 months ]
  • >= 25% increase in systolic blood pressure [ Time Frame: At 1 month, 2 months, 3 months, 4 months and 5 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction
Official Title  ICMJE Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction
Brief Summary

Part I: Week 0-12: Quantify the effects of lower heart rate (HR) elevation on symptoms and function in patients with heart failure with preserved ejection fraction (HFpEF).

The investigators hypothesize that a personalized lower HR elevation employing physiological conduction system pacing in patients with HFpEF will decrease left atrial and left ventricular filling pressures. The investigators expect that this will result in a symptomatic and functional improvements and reduce NTproBNP levels. Additionally, HR elevation may have the potential to reduce the risk for heart failure hospitalization, atrial fibrillation (AF), and cerebrovascular stroke as these outcomes are increased in patients with a normal or preserved ejection fraction on HR lowering treatments.

After undergoing pacemaker implantation participants will be randomized to one out of three treatment arms (a) Bachmann's bundle pacing, (b) Bachmann's bundle and His bundle pacing, (c) no pacing with cross-over to alternative treatment arm at week 4 and 8, respectively. The lower pacing rate in arms a and b will be programmed to the personalized lower heart rate for 24 hours a day (the patient's intrinsic heart rate can exceed the personalized lower rate limit).

Part II: Week 13-20: Determine the effects of nocturnal heart rate elevation on symptoms and function in patients with HFpEF.

The investigators hypothesize that a moderate HR elevation to 110bpm delivered for 10 hours between 8PM to 6AM will provide additional hemodynamic benefits and will lead to beneficial ventricular remodeling.

After week 12 the participant will undergo randomization to one of two treatment arms (a) Bachmann's bundle and His bundle pacing, (b) Bachmann's bundle pacing, His bundle pacing and nocturnal pacing. The participant will cross-over to the other treatment arm after 4 weeks (study week 16).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Heart Failure, Diastolic
Intervention  ICMJE
  • Device: Dual chamber pacemaker
    Dual chamber pacemaker implantation with Bachmann's bundle lead and His bundle lead placement.
  • Other: Accelerated Physiologic Pacing
    The lower rate limit will be programmed to an individualized heart rate.
  • Other: Nocturnal Pacing
    In addition to adjustment of the lower rate limit to an individualized heart rate, nocturnal pacing a moderate HR elevation of 110bpm will be implemented between 8pm and 6am.
Study Arms  ICMJE
  • Placebo Comparator: No pacing
    Intervention: Device: Dual chamber pacemaker
  • Experimental: Bachmann's bundle pacing
    Interventions:
    • Device: Dual chamber pacemaker
    • Other: Accelerated Physiologic Pacing
  • Experimental: Bachmann's bundle and His bundle pacing
    Interventions:
    • Device: Dual chamber pacemaker
    • Other: Accelerated Physiologic Pacing
  • Experimental: Bachmann's bundle, His bundle and nocturnal pacing
    Interventions:
    • Device: Dual chamber pacemaker
    • Other: Accelerated Physiologic Pacing
    • Other: Nocturnal Pacing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Left ventricular ejection fraction ≥ 50% (and diastolic volume < 80ml/m2)
  • Controlled blood pressure for at least 30 days (BP < 130/80mmHg)
  • Heart failure hospitalization within the past 12 months OR Echocardiogram within the past 24 months that reported left ventricular hypertrophy AND an NTproBNP >400 with at least one symptom of heart failure (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea) and at least one sign of heart failure in the past 12 months (pulmonary edema or pleural effusion on chest x-ray, lower extremity edema, jugular venous distention, rales).
  • Study candidates are expected to remain available for follow-up visits.

Exclusion Criteria:

  • Subject has an implanted cardiac pacemaker or defibrillator
  • Life expectancy is less than 12 months
  • Subject is unable or unwilling to perform the 6 Minute Walk Test and MLHFQ at all scheduled follow up visits
  • Subject has any of the following: uncontrolled hypertension, more than moderate valvular disease, chronic hypoxic respiratory failure requiring supplemental oxygen, long-standing persistent atrial fibrillation
  • Baseline ECG with non-LBBB morphology AND QRS >150ms
  • Subject is currently enrolled or planning to enroll in a potentially confounding trial during the course of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicole Habel, MD 8028472270 nicole.habel@uvmhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04546555
Other Study ID Numbers  ICMJE 00000988
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel L Lustgarten, University of Vermont
Study Sponsor  ICMJE Daniel L Lustgarten
Collaborators  ICMJE Medtronic
Investigators  ICMJE Not Provided
PRS Account University of Vermont
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP