Overview

Impact of Beta-blockers on Physical Function in HFpEF

Status:
Enrolling by invitation
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to understand the impact of beta-blockers on physical function in older adults with heart failure. We will achieve this objective by conducting N-of-1 trials. N-of-1 trials are personalized experiments that test different treatment options in an individual patient.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborator:
The New York Community Trust
Treatments:
Acebutolol
Adrenergic beta-Antagonists
Atenolol
Betaxolol
Bisoprolol
Carvedilol
Labetalol
Metoprolol
Nadolol
Nebivolol
Penbutolol
Pindolol
Propranolol
Sotalol
Criteria
Inclusion Criteria:

- 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 Criteria:

- Alternate Causes of HFpEF Syndrome:

1. Severe valvular disease

2. Constrictive pericarditis

3. High output heart failure

4. Infiltrative cardiomyopathy

- Other compelling indication for beta blocker

1. Prior EF < 50%

2. Hypertrophic cardiomyopathy

3. Angina symptoms

4. Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery
in prior 3 year

5. History of ventricular tachycardia

6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1
year

7. 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)

1. Decompensated HF

2. Hospitalized in past 30 days

3. Medication changes or procedures in prior 14 days (to prevent confounding from
other interventions)

- 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