Heart Failure With Preserved Ejection FractionHFpEF-BBNCT05174351
Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction
A study testing beta blocker discontinuation in people with Heart Failure With Preserved Ejection Fraction, run by UConn Health at 1 site in United States.
Trial summary
This is a prospective pilot study to evaluate changes before and 4 weeks after beta-blocker withdrawal in 30 HFpEF patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- beta blocker discontinuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2021to 1 Nov 2027
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable HFpEF patients with NYHA Class II-III or elevated BNP ≥100
- N=30 (Target: 30).
- Age: 50 ~ 80 years.
- ECHO evidence of EF ≥50% and Grade 2 or 3 diastolic dysfunction.
- Chronic loop diuretic use
- Currently on beta-blocker
Who cannot join
- Beta blocker was prescribed for treating other cardiac conditions such as atrial fibrillation or coronary artery disease.
- Heart rate > 100 bpm
- Recent hospitalization due to HF within 3 months
- Non-English speaker
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, 1 recruiting
- Recruiting
UConn Health / John Dempsey Hospital
Farmington, Connecticut, 06030
Kai Chen, MD, PhD, 860-679-3343, kachen@uchc.edu
About this study
Official title: Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
This is a prospective pilot study to evaluate changes before and 4 weeks after beta-blocker withdrawal in 30 HFpEF patients.
Read the detailed description
This is a prospective pilot study to evaluate changes before and 4 weeks(+/- 1 week) after beta-blocker withdrawal in 30 HFpEF patients. The study involves 2 visits that are 4 weeks apart. The first study visit will occur at a standard of care clinic visit and the second visit will be a research visit to fill out questionnaires and perform the limited echocardiogram. No long term follow up beyond the 2nd visit.
- Being tested
- beta blocker discontinuation
- Keywords
- HFpEF, Beta-blocker, echocardiogram, 6MWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta blocker discontinuationOther
beta blocker discontinuation
| Study group | Role | What they receive |
|---|---|---|
| HFpEF patients | Experimental | HFpEF patient who are currently taking beta blockers Receives: Other: beta blocker discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in KCCQ-23 score
Kansa city cardiomyopathy questionnaire (KCCQ-23)- self-administered, 23-item. questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. Scores are transformed to a range of 0-100, where higher scores reflect better health status.
Measured: Baseline and after 4 weeks of beta blocker discontinuation
Secondary outcomes (3)
Changes in cardiac mechanics by echocardiography
Echocardiographic E/e' ratio
Measured: Baseline and after 4 weeks of beta blocker discontinuation
Changes in biomarker
changes from baseline in BNP level (pg/mL) after 4 weeks of beta blocker discontinuation
Measured: Baseline and after 4 weeks of beta blocker discontinuation
6 minute walk test
The distance (meters) covered over a time of 6 minutes. A greater distance indicates a better exercise capacity.
Measured: Baseline and after 4 weeks of beta blocker discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start20 Dec 2021
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Pickett, UConn Health
- Investigators
- Kai Chen, MD,PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174351
- Sponsor's protocol ID
- 22-145-2
- Acronym
- HFpEF-BB
- Status last verified
- Jul 2025
- First submitted
- 2 Dec 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT05174351
- Acronym / sponsor ID
- HFpEF-BB / 22-145-2
- Keywords
- HFpEF, Beta-blocker, echocardiogram, 6MWT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 30 Dec 2021 (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.
This is a prospective pilot study to evaluate changes before and 4 weeks after beta-blocker withdrawal in 30 HFpEF patients.
Detailed description
This is a prospective pilot study to evaluate changes before and 4 weeks(+/- 1 week) after beta-blocker withdrawal in 30 HFpEF patients. The study involves 2 visits that are 4 weeks apart. The first study visit will occur at a standard of care clinic visit and the second visit will be a research visit to fill out questionnaires and perform the limited echocardiogram. No long term follow up beyond the 2nd visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFpEF patients | Experimental | Other: beta blocker discontinuationHFpEF patient who are currently taking beta blockers |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stable HFpEF patients with NYHA Class II-III or elevated BNP ≥100
- N=30 (Target: 30).
- Age: 50 ~ 80 years.
- ECHO evidence of EF ≥50% and Grade 2 or 3 diastolic dysfunction.
- Chronic loop diuretic use
Key exclusion criteria (4 listed)
- Beta blocker was prescribed for treating other cardiac conditions such as atrial fibrillation or coronary artery disease.
- Heart rate > 100 bpm
- Recent hospitalization due to HF within 3 months
- Non-English speaker
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 |
|---|---|---|
| beta blocker discontinuationbeta blocker discontinuation | Other | HFpEF patients |
Primary outcome
Changes in KCCQ-23 score
Time frame: Baseline and after 4 weeks of beta blocker discontinuation
Kansa city cardiomyopathy questionnaire (KCCQ-23)- self-administered, 23-item. questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. Scores are transformed to a range of 0-100, where higher scores reflect better health status.
3 secondary outcomes
Changes in cardiac mechanics by echocardiography
Time frame: Baseline and after 4 weeks of beta blocker discontinuation
Changes in biomarker
Time frame: Baseline and after 4 weeks of beta blocker discontinuation
6 minute walk test
Time frame: Baseline and after 4 weeks of beta blocker discontinuation
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 29 Sep 2025.
- Individual participant dataSharing planned: No
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The Clinical Trial of Tamibarotene for Patients With HFpEF (RELIEF Trial)
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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.
Kai Chen, MD,PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beta blocker discontinuation in people with Heart Failure With Preserved Ejection Fraction, run by UConn Health 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 4 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Kai Chen, MD,PhD (860-679-3343, kachen@uchc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in KCCQ-23 score (time frame: Baseline and after 4 weeks of beta blocker discontinuation). 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 29 Sep 2025.