Status:
COMPLETED
Pilot Deprescribing N-of-1 Trials for Beta-blockers in HFpEF
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Heart Failure
Heart Failure, Diastolic
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
In this study, we will test the feasibility of N-of-1 trials for deprescribing beta-blockers in patients with Heart Failure with Preserved Ejection Fraction. To achieve this objective we will conduct ...
Eligibility Criteria
Inclusion
- Ambulatory adults ≥65 years of age with Heart Failure with Preserved Ejection Fraction (HFpEF) according to ACC/AHA guidelines: (signs and symptoms of Heart failure \[HF\] and ejection fraction \[EF\] ≥50%)
- Taking Beta blocker
Exclusion
- Alternate Causes of HFpEF Syndrome:
- Severe valvular disease
- Constrictive pericarditis
- High output heart failure
- Infiltrative cardiomyopathy
- Other compelling indication for beta blocker:
- Prior EF \< 50%
- Hypertrophic cardiomyopathy
- Angina symptoms
- Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 year
- History of ventricular tachycardia
- Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
- Sinus tachycardia \> 100 beats per minute (bpm), atrial arrhythmia with ventricular rate \>90 bpm, systolic blood pressure \> 160 mmHg
- Clinical instability (N-of-1 trials are appropriate for stable conditions only)
- Decompensated HF
- Hospitalized in past 30 days
- Medication changes or procedures in prior 14 days (to prevent confounding from other interventions), at PI discretion
- Estimated life expectancy \<6 months
- Moderate-severe dementia or psychiatric disorder precluding informed consent
- Any condition that, in Principal Investigator's opinion, makes the patient unsuitable for study participation
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04757584
Start Date
April 1 2021
End Date
April 28 2023
Last Update
April 9 2024
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10065