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Completed

NCT Number: NCT04546555

Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction

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).

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Key information

Conditions

Heart Failure, Diastolic Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Left ventricular ejection fraction ≥ 55% (and diastolic volume < 80ml/m2)
  • Controlled blood pressure: average blood pressure <130/80 mmHg on office visits in the last 30 days or on home blood pressure log or patient has completed up-titration of antihypertensive medications
  • 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 (average blood pressure of >140/90 on office visits in the last 30 days or on home blood pressure log or actively undergoing uptitration of antihypertensive medication), 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

Treatment and study plan

Dual Chamber Pacemaker

Device

Dual chamber pacemaker implantation with Bachmann's bundle lead and His bundle lead placement.

Accelerated Physiologic Pacing

Other

The lower rate limit will be programmed to an individualized heart rate.

Nocturnal Pacing

Other

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.

Primary outcomes

  1. 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

  2. Percent change in NTproBNP

    Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months

Secondary outcomes

  1. Change in 6 minute walk test

    Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months

  2. Incident AF

    Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months

  3. Burden of AF

    Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months

  4. Hemodynamic changes by Echo

    Time frame: At 3 months and at 5 months

  5. Change in left ventricular mass/volume ratio by cardiac MRI

    Time frame: 5 months

Other outcomes

  1. 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

  2. Doubling in baseline Troponin or NTproBNP

    Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months

  3. >= 25% increase in systolic blood pressure

    Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months

Sponsors and collaborators

Lead sponsor

Daniel L Lustgarten

Other

Collaborators

  • Medtronic

Registry information

Acronym: PACE HFpEF

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2020
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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