Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: beta blocker discontinuation.
- Who it may be relevant to
- Registry conditions: Heart Failure With Preserved Ejection Fraction. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
Overview
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.
Interventions
- Other beta blocker discontinuation
beta blocker discontinuation
Primary outcome measures
- Changes in KCCQ-23 score [Time frame: Baseline and after 4 weeks of beta blocker discontinuation]
Secondary outcome measures (3)
- Changes in cardiac mechanics by echocardiography [Time frame: Baseline and after 4 weeks of beta blocker discontinuation]
- Changes in biomarker [Time frame: Baseline and after 4 weeks of beta blocker discontinuation]
- 6 minute walk test [Time frame: Baseline and after 4 weeks of beta blocker discontinuation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UConn Health / John Dempsey Hospital — Farmington
Identifiers
NCT: NCT05174351 · 22-145-2