An interventional study of Dual chamber pacemaker and Accelerated Physiologic Pacing in Heart Failure, Diastolic, sponsored by Daniel L Lustgarten. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-28.
Sponsored by Daniel L Lustgarten · Not applicable, Interventional, and Other
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).
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Daniel L Lustgarten as lead sponsor.
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Exclusion Criteria:
Device: Dual chamber pacemaker
Device: Dual chamber pacemaker · Other: Accelerated Physiologic Pacing
Device: Dual chamber pacemaker · Other: Accelerated Physiologic Pacing
Device: Dual chamber pacemaker · Other: Accelerated Physiologic Pacing · Other: Nocturnal Pacing
Dual chamber pacemaker implantation with Bachmann's bundle lead and His bundle lead placement.
The lower rate limit will be programmed to an individualized heart rate.
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.
Change in composite Minnesota-Living-with-Heart-Failure-Questionnaire score
Total score can range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life
Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months
Percent change in NTproBNP
Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months
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
Quantitative assessment of the risks of pacemaker implantation
Incidence of pocket hematoma, pocket infection phrenic or diaphragmatic stimulation, lead endocarditis, lead dysfunction/dislocation, pneumothorax, hemopericardium, mortality
Time frame: 1 month
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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