Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction

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

Detailed Description
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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.

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

Conditions
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Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
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* Other: beta blocker discontinuation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFpEF patients<br>HFpEF patient who are currently taking beta blockers | Other: beta blocker discontinuation<br>* beta blocker discontinuation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac mechanics by echocardiography | Echocardiographic E/e' ratio | Baseline and after 4 weeks of beta blocker discontinuation | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta-blocker, echocardiogram, HFpEF, 6MWT