Heart Failure, HFpEF, HFpEF - Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
Heart Failure, Heart Failure with Preserved Ejection Fraction, HFPEF, Deprescribing
Brief summary
The goal of this study is to learn whether stopping beta-blockers can help older adults with heart failure with preserved ejection fraction (HFpEF) feel better and function better. This study will test whether "deprescribing" or stopping these medications in a careful, guided way can improve symptoms and quality of life. Participants will be randomly assigned to one of two groups: Deprescribing group: Beta-blockers are gradually reduced using capsules that contain decreasing doses. Usual care group: Beta-blockers are continued at the usual dose in look-alike capsules. All participants will: * Take study medicine for about 4 months * Have their blood pressure and heart rate monitored * Complete regular phone calls and questionnaires about how they are feeling This study does not involve any experimental medication. Participants active involvement in the study will last approximately 4 months. During these 4 months they will have 8 scheduled telephone visits.
Interventions
Beta-blocker dosage will be reduced over the course of 4 weeks until the participant is completely off of beta-blocker and transitioned to matching placebo capsules.
DRUGBeta-blockers
Participants will continue their pre-enrollment beta-blocker at the same dose. The beta-blocker agent may include atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate. Medication will be provided in matching capsules to maintain blinding.
Sponsors
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Kaiser Foundation Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ambulatory adults age ≥60 years with HFpEF (EF ≥50% based on most recent transthoracic echocardiogram) 2. Hospitalized with HF in the past 24 months (defined by diagnostic codes in any position) 3. Taking any of the following ß-blockers: atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate (i.e., pharmacy prescription data) 4. Kaiser Permanence Northern California Membership
Exclusion criteria
1. Alternative etiologies of HFpEF syndrome 2. Compelling guideline indication for ß-blocker: * Prior EF \<50% (i.e., based on the structured data field on transthoracic echocardiogram) * Current anginal symptoms (i.e., based on the Rose Angina single-question screener for angina) * MI (i.e., diagnostic codes) and/or coronary revascularization (i.e., procedure codes) within 3 years * Hospitalization for a primary discharge diagnosis of atrial fibrillation or atrial flutter in the prior 12 months * Other documented reason in the opinion of the treating provider and/or enrolling clinician-investigator 3. Evidence of recent decompensated HF * Hospitalization for a primary discharge diagnosis of HF within the past 30 days * Change in loop diuretic pharmacy prescription in the past 30 days (i.e. pharmacy prescription data) (Note: This definition is based on documented prescription changes and does not include short-term dose adjustments that were verbally communicated to the patient by their provider.) 4. Estimated life expectancy \<6 months (i.e., diagnostic codes) 5. Diagnosed dementia (i.e.., diagnostic codes) 6. Unable to provide informed consent 7. Loss of Kaiser Permanence Northern California Membership
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Hierarchical Composite Endpoint | From baseline (day 0) to end of the follow-up phase (day 120) | The primary outcome is net benefit, assessed using a hierarchical composite of four patient-centered outcomes: (1) time to death from any cause, (2) time to all-cause hospitalization, (3) ≥ 5-point difference of KCCQ-12 OSS change from baseline, and (4) ≥ 3-point difference in PROMIS Depression T-score change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in patient-reported mental health, as measured by the PROMIS Depression scale | Baseline, Day 120 | The PROMIS Depression scale is a validated 4-item patient-reported measure developed by the NIH, with high reliability and responsiveness in older adults. The 4-item questionnaire asks participants to rate their agreement with a series of statements using a six-point Likert scale, ranging from "never" (0) to "always" (5). Item responses are summed to generate a raw score ranging from 4 to 20, which is then converted to a standardized T-score using PROMIS scoring guidelines. Higher scores indicate greater depressive symptom severity. |
| The change from baseline in patient-reported physical health, as measured by the KCCQ-12 | Baseline, Day 120 | The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a heart failure-specific health status survey. The 12-item questionnaire asks participants to rate their agreement with a series of statements using a six-point Likert scale, ranging from "completely disagree" (0) to "completely agree" (5). Item responses are summed to generate a total score ranging from 0 to 100, with higher scores indicating better health status. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORParag Goyal, MD, MSc
Weill Medical College of Cornell University
PRINCIPAL_INVESTIGATORAndrew Ambrosy, MD, MPH
Kaiser Permanente
Outcome results
None listed