Overview

Pilot Deprescribing Trials for Beta-blockers in Cardiac Amyloidosis

Status:
Not yet recruiting

Trial end date:
2023-09-01

Target enrollment:
0

Participant gender:
All

Summary

In this study, the investigators will test the feasibility of N-of-1 trials for deprescribing beta-blockers in patients with Cardiac Amyloidosis. To achieve this objective, 16 N-of-1 trials (on vs. off) will be conducted and subsequently interview participants to better understand feasibility and pragmatism. Each subject can participate in a total of up to 4 periods lasting between 2-6 weeks each based on each patients' health profile. The N-of-1 trials will be iteratively refined in real-time based on feedback.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Weill Medical College of Cornell University

Treatments:

Adrenergic beta-Antagonists

Criteria

Inclusion Criteria:

1. Ambulatory adults age ≥65 years with TTR-cardiac amyloidosis (confirmed by PYP scan or
biopsy)

2. Taking beta-blocker

Exclusion Criteria:

1. Alternate causes of HFpEF Syndrome:

1. Severe aortic stenosis and mitral stenosis

2. Constrictive pericarditis

3. High Output HF

2. Other compelling indication beta-blocker

1. Hypertrophic cardiomyopathy

2. Angina symptoms

3. Acute coronary syndrome, myocardial infraction or coronary artery bypass surgery
in prior 3 years

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

5. Sinus tachycardia >100 bpm, atrial arrhythmia with ventricular rate >90 beats per
minute, systolic blood pressure >160 mmHg

3. Clinical instability (N-of-1 trials are appropriate for stable conditions only)

1. Decompensated heart failure

2. Hospitalized in past 30 days

3. Medication changes or procedures in prior 14 days that could confound
observations, per PI discretion

4. Estimated life expectancy <6 months

5. Moderate-severe dementia or psychiatric disorder precluding informed consent

6. Any condition that, in Principal Investigator's opinion, makes the patient unsuitable
for study participation