Clinical Trial: N-of-1 for Beta-Blockers in Cardiac Amyloidosis

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: N-of-1 Trials to Promote Deprescribing in Older Adults With Transthyretin Cardiac Amyloidosis

Brief 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.

Detailed Summary: 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.
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: To understand the changes in exercise capacity between the On and Off phase via a Peak oxygen consumption (VO2) Cardiopulmonary Exercise Test.
Cardiopulmonary exercise testing (CPET) measures breath-by-breath oxygen production during symptom-limited exercise on a stationary bike or treadmill.
This permits calculation of peak oxygen consumption (VO2).
Percent predicted peak VO2 for body weight will also be calculated.

Original Primary Outcome: To understand the changes in exercise capacity between the On and Off phase via a Peak oxygen consumption (VO2) Cardiopulmonary Exercise Test.
Cardiopulmonary exercise testing (CPET) measures breath-by-breath oxygen production during symptom-limited exercise on a stationary bike or treadmill.
This permits calculation of peak oxygen consumption (VO2).
Percent predicted peak VO2 for body weight will also be calculated.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Weill Medical College of Cornell University

Dates:
Date Received: August 17, 2021
Date Started: January 01, 2024
Date Completion: January 01, 2024
Last Updated: December 04, 2023
Last Verified: December 01, 2023