Deprescribing Beta-Blockers in Elders With Heart Failure With Preserved Ejection Fraction (DEPRESCRIBE-HFpEF)
NCT ID: NCT07298993
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
240 participants
INTERVENTIONAL
2026-01-31
2029-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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Deprescribe
Participants will have their beta-blocker replaced with pills that have decreasing amounts of beta-blocker until they are completely off their medicine and taking placebo pills.
Placebo (matching)
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.
Continuation
Participants will continue their beta-blocker at their usual dose in capsules that look identical to those used for the deprescribe arm.
Beta-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.
Interventions
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Placebo (matching)
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.
Beta-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
60 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Kaiser Foundation Research Institute
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Parag Goyal, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Andrew Ambrosy, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Kaiser Permanente Northern California (KPNC)
Pleasanton, California, United States
Countries
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Central Contacts
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Facility Contacts
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Zara Fatima
Role: primary
Other Identifiers
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24-08027899
Identifier Type: -
Identifier Source: org_study_id