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NCT Number: NCT05174351

Beta-blocker Discontinuation in 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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Health / John Dempsey Hospital

Farmington, Connecticut, 06030, United States

Location status: Recruiting

Location contact

Kai Chen, MD, PhD

CONTACT

[email protected]

860-679-3343

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

beta blocker discontinuation

Other

beta blocker discontinuation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in cardiac mechanics by echocardiography

    Time frame: Baseline and after 4 weeks of beta blocker discontinuation

    Echocardiographic E/e' ratio

  2. Changes in biomarker

    Time frame: Baseline and after 4 weeks of beta blocker discontinuation

    changes from baseline in BNP level (pg/mL) after 4 weeks of beta blocker discontinuation

  3. 6 minute walk test

    Time frame: Baseline and after 4 weeks of beta blocker discontinuation

    The distance (meters) covered over a time of 6 minutes. A greater distance indicates a better exercise capacity.

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Chen, MD,PhD

CONTACT

[email protected]

860-679-3343

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Registry information

Official study title

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

Acronym: HFpEF-BB

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2021
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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