Diastolic Dysfunction, Diastolic Heart Failure, Pacemaker
Conditions
Keywords
Heart failure with preserved ejection fraction, Diastolic dysfunction, Resting heart rate, Personalized, Lower rate setting
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.
Interventions
DEVICEAdjustment of lower rate limit
Patients with preserved ejection fraction (EF \>50%) and implanted pacemakers will have the lower rate limit adjusted to a personalized heart rate based on a heart rate algorithm.
DEVICEMaintenance of lower rate limit
Lower rate limit will be maintained at 60 beats-per-minute
Sponsors
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
All investigators are blinded to patient randomization. To assess subject blinding, participants are asked at 1 month and 12 month follow up if they believed that their pacemaker lower rate was changed.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minnesota Living with Heart Failure Questionnaire Score | Baseline, 1 month, and 12 months | Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization or invasive outpatient intervention for heart failure | At 12 months | — |
| Atrial Arrhythmia Burden | At 12 months | On pacemaker reports |
| Loop diuretic initiation or up-titration | At 12 months | — |
| NTproBNP | Baseline, 1 month | Change in NTproBNP level from baseline to 1 month |
| Pacemaker-detected activity levels | At 12 months | — |
| hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction | At 12 months | — |
| Anti-arrhythmic initiation or up-titration | At 12 months | — |
Countries
United States
Outcome results
None listed