N-of-1 for Beta-Blockers in Cardiac Amyloidosis

Heart Diseases Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis
• Heart Diseases

• NCT number: NCT05019027
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Contact: Princess Osma, BA
• Phone: 646-962-5910
• Email: pro4001@med.cornell.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: January 31, 2024
• Completion date: September 2025