Transthyretin Amyloid Cardiomyopathy Clinical Trial
N-of-1 for Beta-Blockers in Cardiac Amyloidosis
Summary
The study team will generate preliminary data on whether patients with cardiac amyloidosis feel better when their beta-blocker is stopped. To achieve this objective, 20 N-of-1 trials (on vs. off) will be conducted, and the study team will subsequently interview participants to better understand their outcomes. Each subject will participate in 2 periods lasting between up to 6 weeks each based on each patient's health profile. We will also engage stakeholders to understand the acceptability and feasibility of deprescribing N-of-1 trials. The N-of-1 trials will be iteratively refined in real-time based on feedback.
Full Description
The intervention is an unblinded NIH Stage I of Behavioral Intervention Development trial, using a single-arm crossover withdrawal/reversal design (On [A] vs. Off [B]) with 2 periods, each period lasting up to 6 weeks, allowing for down-titration and washout. During the On (A) period, subjects will be on their beta-blocker, previously prescribed to the subjects by their physician. During the Off (B) period, their beta-blockers will be down-titrated and subsequently discontinued; we will decrease the dose of beta-blocker by 50% every week regardless of which beta-blocker they are on, similar to an algorithm used in a prior deprescribing trial.
Eligibility Criteria
Inclusion Criteria:
Ambulatory adults age ≥65 years with TTR-cardiac amyloidosis (confirmed by PYP scan or biopsy)
Taking beta-blocker
Exclusion Criteria:
Other compelling indication beta-blocker
Angina symptoms
Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 years
Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
Sinus tachycardia >100 bpm, atrial arrhythmia with ventricular rate >90 beats per minute, systolic blood pressure >160 mmHg
Clinical instability (N-of-1 trials are appropriate for stable conditions only)
Decompensated heart failure
Hospitalized in past 30 days
Medication changes or procedures in the prior 14 days that could confound observations, per the Principal Investigator's discretion
Estimated life expectancy <6 months
Moderate-severe dementia or psychiatric disorder precluding informed consent
Language barrier that will preclude informed consent and ability to comprehend study procedures
Non-compliance or inability to complete study procedures
Enrollment in a clinical trial not approved for co-enrollment
Any condition that, in Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation
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There is 1 Location for this study
New York New York, 10065, United States More Info
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