Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction

Heart Failure With Preserved Ejection Fraction Clinical Trial

— HFpEF-BB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174351
• Other study ID #: 22-145-2
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: March 2022
• Source: UConn Health
• Contact: Kai Chen, MD,PhD
• Phone: 860-679-3343
• Email: kachen[@]uchc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Other:
• beta blocker discontinuation
beta blocker discontinuation

Locations

Country	Name	City	State
United States	UConn Health / John Dempsey Hospital	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
UConn Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in cardiac mechanics by echocardiography	Echocardiographic E/e' ratio	Baseline and after 4 weeks of beta blocker discontinuation
Secondary	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
Secondary	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