Back to resultsBeta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction (HFpEF-BB)
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
beta blocker discontinuation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring HFpEF, Beta-blocker, echocardiogram, 6MWT
Eligibility Criteria
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
Sites / Locations
- UConn Health / John Dempsey HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HFpEF patients
Arm Description
HFpEF patient who are currently taking beta blockers
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in cardiac mechanics by echocardiography
Echocardiographic E/e' ratio
Changes in biomarker
changes from baseline in BNP level (pg/mL) 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05174351
Brief Title
Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction
Acronym
HFpEF-BB
Official Title
Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
HFpEF, Beta-blocker, echocardiogram, 6MWT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFpEF patients
Arm Type
Experimental
Arm Description
HFpEF patient who are currently taking beta blockers
Intervention Type
Other
Intervention Name(s)
beta blocker discontinuation
Intervention Description
beta blocker discontinuation
Primary Outcome Measure Information:
Title
Changes in KCCQ-23 score
Description
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.
Time Frame
Baseline and after 4 weeks of beta blocker discontinuation
Secondary Outcome Measure Information:
Title
Changes in cardiac mechanics by echocardiography
Description
Echocardiographic E/e' ratio
Time Frame
Baseline and after 4 weeks of beta blocker discontinuation
Title
Changes in biomarker
Description
changes from baseline in BNP level (pg/mL) after 4 weeks of beta blocker discontinuation
Time Frame
Baseline and after 4 weeks of beta blocker discontinuation
Title
6 minute walk test
Description
The distance (meters) covered over a time of 6 minutes. A greater distance indicates a better exercise capacity.
Time Frame
Baseline and after 4 weeks of beta blocker discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Chen, MD,PhD
Phone
860-679-3343
Email
kachen@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Chen, MD,PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health / John Dempsey Hospital
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Chen, MD, PhD
Phone
860-679-3343
Email
kachen@uchc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction
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