Health TrialsbyHealthPanel

Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction

ConditionHeart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUConn Health

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • beta blocker discontinuation

    Other intervention

    beta blocker discontinuation

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: HFpEF patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and after 4 weeks of beta blocker discontinuation

Secondary outcomes

1

Changes in cardiac mechanics by echocardiography

Echocardiographic E/e' ratio

Time frame
Baseline and after 4 weeks of beta blocker discontinuation
2

Changes in biomarker

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
3

6 minute walk test

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UConn Health

Lead sponsor

Source ClinicalTrials.gov
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