Heart FailurePhase 4DEPRESCRIBENCT07298993
Deprescribing Beta-Blockers in Elders With Heart Failure With Preserved Ejection Fraction (DEPRESCRIBE-HFpEF)
A Phase 4 study testing Beta-blockers in people with Heart Failure and HFpEF, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure, HFpEF, HFpEF - Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Beta-blockers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to Apr 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory adults age ≥60 years with HFpEF (EF ≥50% based on most recent transthoracic echocardiogram)
- Evidence of HF, defined by at least one of the following:
- Hospitalized with HF in the past 24 months (defined by diagnostic codes in any position)
- BNP >100 pg/mL in the past 24 months
- Taking any of the following ß-blockers: atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate (i.e., pharmacy prescription data)
- Kaiser Permanente Northern California Membership
Who cannot join
- 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 with a rapid ventricular response in the prior 12 months (i.e., not for an elective procedure such as a cardioversion or an ablation)
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- Other documented reason in the opinion of the treating provider and/or enrolling clinician-investigator
- Hospitalization for a primary discharge diagnosis of HF within the past 30 days.
- Estimated life expectancy <6 months (i.e., diagnostic codes)
- Diagnosed dementia (i.e., diagnostic codes)
- Unable to provide informed consent
- Loss of Kaiser Permanente Northern California Membership
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente Northern California (KPNC)
Pleasanton, California, 94588
About this study
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)
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:
Read more
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.
- Being tested
- Placebo (matching), Beta-blockers
- Keywords
- Heart Failure, Heart Failure with Preserved Ejection Fraction, HFPEF, Deprescribing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (matching)Drug
Also called Deprescribing
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-blockersDrug
Also called Atenolol, Bisoprolol, Carvedilol, Metoprolol succinate
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.
| Study group | Role | What they receive |
|---|---|---|
| Deprescribe | Placebo comparator | 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. Receives: Drug: Placebo (matching) |
| Continuation | Active comparator | Participants will continue their beta-blocker at their usual dose in capsules that look identical to those used for the deprescribe arm. Receives: Drug: Beta-blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hierarchical Composite Endpoint
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
Measured: From baseline (randomization) to 120 days after study drug initiation
Secondary outcomes (2)
The change from baseline in patient-reported physical health, as measured by the KCCQ-12
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.
Measured: From baseline (randomization) to 120 days after study drug initiation
The change in patient-reported mental health, as measured by the PROMIS Depression scale
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.
Measured: From baseline (randomization) to 120 days after study drug initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start2 Feb 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Kaiser Foundation Research Institute
- Responsible party
- Sponsor
- Investigators
- Parag Goyal, MD, MSc, Principal investigator, Weill Medical College of Cornell UniversityAndrew Ambrosy, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298993
- Sponsor's protocol ID
- 24-08027899
- Other IDs
- R01AG091005
- Acronym
- DEPRESCRIBE
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for this study will be shared only after the publication of findings addressing the study's specific aims. Data generated under this project will be managed in accordance with the policies of Weill Cornell Medicine (WCM) and the NIH, including the NIH Data Sharing Policy and Implementation Guidance. After publication of our main findings, data will be made available for secondary analyses. External researchers may request access to the data by submitting a written proposal outlining the hypotheses to be tested. All data will be de-identified to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07298993
- Acronym / sponsor ID
- DEPRESCRIBE / 24-08027899
- Keywords
- Heart Failure, Heart Failure with Preserved Ejection Fraction, HFPEF, Deprescribing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Kaiser Foundation Research Institute
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deprescribe | Placebo comparator | Drug: Placebo (matching)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. |
| Continuation | Active comparator | Drug: Beta-blockersParticipants will continue their beta-blocker at their usual dose in capsules that look identical to those used for the deprescribe arm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ambulatory adults age ≥60 years with HFpEF (EF ≥50% based on most recent transthoracic echocardiogram)
- Evidence of HF, defined by at least one of the following:
- Taking any of the following ß-blockers: atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate (i.e., pharmacy prescription data)
- Kaiser Permanente Northern California Membership
Key exclusion criteria (12 listed)
- Alternative etiologies of HFpEF syndrome
- Compelling guideline indication for ß-blocker:
- Hospitalization for a primary discharge diagnosis of HF within the past 30 days.
- Estimated life expectancy <6 months (i.e., diagnostic codes)
- Diagnosed dementia (i.e., diagnostic codes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (matching)Also: DeprescribingBeta-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 | Deprescribe |
| Beta-blockersAlso: Atenolol, Bisoprolol, Carvedilol, Metoprolol succinateParticipants 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. | Drug | Continuation |
Primary outcome
The Hierarchical Composite Endpoint
Time frame: From baseline (randomization) to 120 days after study drug initiation
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
2 secondary outcomes
The change from baseline in patient-reported physical health, as measured by the KCCQ-12
Time frame: From baseline (randomization) to 120 days after study drug initiation
The change in patient-reported mental health, as measured by the PROMIS Depression scale
Time frame: From baseline (randomization) to 120 days after study drug initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Data collected for this study will be shared only after the publication of findings addressing the study's specific aims. Data generated under this project will be managed in accordance with the policies of Weill Cornell Medicine (WCM) and the NIH, including the NIH Data Sharing Policy and Implementation Guidance. After publication of our main findings, data will be made available for secondary analyses. External researchers may request access to the data by submitting a written proposal outlining the hypotheses to be tested. All data will be de-identified to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Parag Goyal, MD, MSc principal investigator
Weill Medical College of Cornell University
Andrew Ambrosy, MD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta-blockers in people with Heart Failure and HFpEF, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hierarchical Composite Endpoint (time frame: From baseline (randomization) to 120 days after study drug initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.