Heart Failure Clinical Trial
Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
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
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There is 1 Location for this study
Burlington Vermont, 05401, United States
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