Clinical trial NCT04721314: Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
Official title: Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker
Diastolic Dysfunction
Diastolic Heart Failure
Keywords: Heart failure with preserved ejection fraction
Diastolic dysfunction
Resting heart rate
Personalized
Lower rate setting
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to either a personalized pacemaker lower heart rate setting based on a resting heart rate algorithm or to the conventional pacemaker lower rate setting of 60bpm.
Primary purpose: TREATMENT

Brief summary: Recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) may benefit from a higher backup heart rate (HR) setting than the factory setting of 60 beats per minute (bpm). In this prospective double-blinded randomized controlled study, pacemaker patients with DD or overt HFpEF and either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing will be enrolled and randomized to either a personalized lower HR setting (myPACE group, based on a height-based HR algorithm) or to the standard 60bpm backup setting (control group) for 1 year.


Eligibility criteria: Inclusion Criteria:

* Implanted pacemaker with either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing or 3) RV pacing \<2% and paced QRS duration \<150ms
* Clinical evidence of heart failure with preserved ejection fraction or diastolic dysfunction, based on:

  * dyspnea with exertion
  * or NYHA Class ≥ II heart failure
  * or pulmonary edema on prior chest imaging or documented on exam
  * or is taking loop diuretics for heart failure
  * or had NTproBNP \>400 ng/ml in the last 24 months
  * or a heart failure hospitalization in the last 2 years
  * or has diastolic dysfunction on echo
  * or has left ventricular hypertrophy on echo
  * or has left atrial (LA) dilation (LA volume/BSA index \>28ml/m2)

Exclusion Criteria:

* Left ventricular ejection fraction \< 50%
* Life expectancy \< 12 months
* Symptomatic pulmonary disease on home oxygen
* Uncontrolled hypertension as defined by blood pressure \>160/100 mmHg on two checks ≥15 minutes apart
* Hypertrophic cardiomyopathy
* More than moderate valvular disease
* Aortic valve replacement \< 1 year
* Angina pectoris
* Creatinine \> 2
* Hemoglobin \< 8 g/dL
* Participation in another clinical trial or registry study
* Inability to follow up for regularly scheduled pacemaker appointments or to follow up for this study
* Pregnant patients or patients of childbearing age without reliable contraceptive agent (intra-uterine device, birth control implant, compliance with contraception injections or contraception pills) for the duration of study participation

Primary outcomes:
measure: Minnesota Living with Heart Failure Questionnaire Score
timeFrame: Baseline, 1 month, and 12 months
Secondary outcomes:
measure: NTproBNP
timeFrame: Baseline, 1 month
measure: Hospitalization or invasive outpatient intervention for heart failure
timeFrame: At 12 months
measure: Atrial Arrhythmia Burden
timeFrame: At 12 months
measure: Loop diuretic initiation or up-titration
timeFrame: At 12 months
measure: Anti-arrhythmic initiation or up-titration
timeFrame: At 12 months
measure: Pacemaker-detected activity levels
timeFrame: At 12 months
measure: hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction
timeFrame: At 12 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: University of Minnesota
name: Markus Meyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: