Status:
COMPLETED
Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
University of Vermont
Conditions:
Pacemaker
Diastolic Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
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) se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2021
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT04721314
Start Date
July 17 2019
End Date
December 5 2021
Last Update
February 9 2022
Active Locations (1)
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1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401