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出境医 / 临床实验 / Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction (HFpEF-BB)

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

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.

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Other: beta blocker discontinuation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
Estimated Study Start Date : December 20, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: HFpEF patients
HFpEF patient who are currently taking beta blockers
 Other: beta blocker discontinuation
beta blocker discontinuation
Outcome Measures
Primary Outcome Measures :
  1. Changes in KCCQ-23 score [ Time Frame: 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 :
  1. Changes in cardiac mechanics by echocardiography [ Time Frame: Baseline and after 4 weeks of beta blocker discontinuation ]
    Echocardiographic E/e' ratio

  2. Changes in biomarker [ Time Frame: Baseline and after 4 weeks of beta blocker discontinuation ]
    changes from baseline in BNP level (pg/mL) after 4 weeks of beta blocker discontinuation

  3. 6 minute walk test [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Kai Chen, MD,PhD 860-679-3343 kachen@uchc.edu

Locations
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United States, Connecticut
UConn Health / John Dempsey Hospital
Farmington, Connecticut, United States, 06030
Contact: Kai Chen, MD, PhD    860-679-3343    kachen@uchc.edu   
Sponsors and Collaborators
UConn Health
Investigators
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Principal Investigator: Kai Chen, MD,PhD UConn Health
Tracking Information
First Submitted Date  ICMJE December 2, 2021
First Posted Date  ICMJE December 30, 2021
Last Update Posted Date December 30, 2021
Estimated Study Start Date  ICMJE December 20, 2021
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2021) 		Changes in KCCQ-23 score [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2021)
  • Changes in cardiac mechanics by echocardiography [ Time Frame: Baseline and after 4 weeks of beta blocker discontinuation ]
    Echocardiographic E/e' ratio
  • Changes in biomarker [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction
Official Title  ICMJE Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure With Preserved Ejection Fraction
Intervention  ICMJE Other: beta blocker discontinuation
beta blocker discontinuation
Study Arms  ICMJE Experimental: HFpEF patients
HFpEF patient who are currently taking beta blockers
Intervention: Other: beta blocker discontinuation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 14, 2021) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2022
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kai Chen, MD,PhD 860-679-3343 kachen@uchc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05174351
Other Study ID Numbers  ICMJE 22-145-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kai Chen, UConn Health
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kai Chen, MD,PhD UConn Health
PRS Account UConn Health
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP