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Enrolling by invitation NCT07298993

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

Phase IV Interventional Heart Failure HFpEF HFpEF - Heart Failure With Preserved Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo (matching), Beta-blockers.
Who it may be relevant to
Registry conditions: Heart Failure, HFpEF, HFpEF - Heart Failure With Preserved Ejection Fraction. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Determining Evidence in a Placebo-Controlled, Randomized Experiment Studying Continuation vs. Removal of Inessential Beta-Blockers in Elders With Heart Failure With Preserved Ejection Fraction (DEPRESCRIBE-HFpEF)

Overview

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

  • Drug 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.
  • Drug 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.

Primary outcome measures

  • The Hierarchical Composite Endpoint [Time frame: From baseline (day 0) to end of the follow-up phase (day 120)]
Secondary outcome measures (2)
  • The change from baseline in patient-reported physical health, as measured by the KCCQ-12 [Time frame: Baseline, Day 120]
  • The change in patient-reported mental health, as measured by the PROMIS Depression scale [Time frame: Baseline, Day 120]

Eligibility criteria

Inclusion criteria

  • Ambulatory adults age ≥60 years with HFpEF (EF ≥50% based on most recent transthoracic echocardiogram)
  • Hospitalized with HF in the past 24 months (defined by diagnostic codes in any position)
  • Taking any of the following ß-blockers: atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate (i.e., pharmacy prescription data)
  • Kaiser Permanence Northern California Membership

Exclusion criteria

  • Alternative etiologies of HFpEF syndrome
  • 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
  • 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.)
  • Estimated life expectancy <6 months (i.e., diagnostic codes)
  • Diagnosed dementia (i.e.., diagnostic codes)
  • Unable to provide informed consent
  • Loss of Kaiser Permanence Northern California Membership

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Kaiser Permanente Northern California (KPNC) — Pleasanton

Identifiers

NCT: NCT07298993 · 24-08027899 · R01AG091005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗