Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction (HFpEF-BB)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Other: beta blocker discontinuation

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kai Chen, MD,PhD; Phone Number: 860-679-3343; Email: kachen@uchc.edu

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • UConn Health / John Dempsey Hospital
      • Contact: Kai Chen, MD, PhD; Phone Number: 860-679-3343; Email: kachen@uchc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFpEF patients; HFpEF patient who are currently taking beta blockers	Other: beta blocker discontinuation; beta blocker discontinuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and after 4 weeks of beta blocker discontinuation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cardiac mechanics by echocardiography	Echocardiographic E/e' ratio	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	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.	Baseline and after 4 weeks of beta blocker discontinuation

Collaborators and Investigators

• Sponsor: UConn Health
• Investigators: Principal Investigator: Kai Chen, MD,PhD, UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: echocardiogram; HFpEF; 6MWT; Beta-blocker
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-Antagonists
• Other Study ID Numbers: 22-145-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No