Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction

Not Applicable

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Other: beta blocker discontinuation

• Registration Number: NCT05174351
• Lead Sponsor: UConn Health

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.

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-14
• Study Start: 2021-12-20
• Study First Posted: 2021-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-17
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HFpEF patients	beta blocker discontinuation	HFpEF patient who are currently taking beta blockers

Primary Outcome Measures

Name	Time	Method
Changes in KCCQ-23 score	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 Outcome Measures

Name	Time	Method
Changes in cardiac mechanics by echocardiography	Baseline and after 4 weeks of beta blocker discontinuation	Echocardiographic E/e' ratio
Changes in biomarker	Baseline and after 4 weeks of beta blocker discontinuation	changes from baseline in BNP level (pg/mL) after 4 weeks of beta blocker discontinuation
6 minute walk test	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.

Trial Locations

Locations (1)

UConn Health / John Dempsey Hospital; 🇺🇸 Farmington, Connecticut, United States