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Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction

Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05174351
Acronym
HFpEF-BB
Enrollment
30
Registered
2021-12-30
Start date
2021-12-20
Completion date
2027-11-01
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

HFpEF, Beta-blocker, echocardiogram, 6MWT

Brief summary

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.

Interventions

OTHERbeta blocker discontinuation

beta blocker discontinuation

Sponsors

UConn Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in KCCQ-23 scoreBaseline and after 4 weeks of beta blocker discontinuationKansa 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.

Secondary

MeasureTime frameDescription
Changes in cardiac mechanics by echocardiographyBaseline and after 4 weeks of beta blocker discontinuationEchocardiographic E/e' ratio
Changes in biomarkerBaseline and after 4 weeks of beta blocker discontinuationchanges from baseline in BNP level (pg/mL) after 4 weeks of beta blocker discontinuation
6 minute walk testBaseline and after 4 weeks of beta blocker discontinuationThe distance (meters) covered over a time of 6 minutes. A greater distance indicates a better exercise capacity.

Countries

United States

Contacts

Primary ContactKai Chen, MD,PhD
kachen@uchc.edu860-679-3343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026