Deprescribing Beta-Blockers in Elders With Heart Failure With Preserved Ejection Fraction (DEPRESCRIBE-HFpEF)

Weill Cornell Medicine (WCM)

Status and phase: Not yet enrolling; Phase 4

Conditions: HFpEF; Heart Failure; HFpEF - Heart Failure With Preserved Ejection Fraction

Treatments: Drug: Beta-blockers; Drug: Placebo (matching)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07298993

24-08027899

R01AG091005 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Deprescribe

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (matching)

Continuation

Active Comparator group

Description:

Participants will continue their beta-blocker at their usual dose in capsules that look identical to those used for the deprescribe arm.

Treatment:

Drug: Beta-blockers