NCT05174351

Brief Summary

This is a prospective pilot study to evaluate changes before and 4 weeks after beta-blocker withdrawal in 30 HFpEF patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Dec 2021Nov 2027

First Submitted

Initial submission to the registry

December 2, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

December 20, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 29, 2025

Status Verified

July 1, 2025

Enrollment Period

5.9 years

First QC Date

December 2, 2021

Last Update Submit

September 23, 2025

Conditions

Keywords

HFpEFBeta-blockerechocardiogram6MWT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in cardiac mechanics by echocardiography

    Baseline and after 4 weeks of beta blocker discontinuation

  • Changes in biomarker

    Baseline and after 4 weeks of beta blocker discontinuation

  • 6 minute walk test

    Baseline and after 4 weeks of beta blocker discontinuation

Study Arms (1)

HFpEF patients

EXPERIMENTAL

HFpEF patient who are currently taking beta blockers

Other: beta blocker discontinuation

Interventions

beta blocker discontinuation

HFpEF patients

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Health / John Dempsey Hospital

Farmington, Connecticut, 06030, United States

RECRUITING

Study Officials

  • Kai Chen, MD,PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Chen, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 30, 2021

Study Start

December 20, 2021

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations