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ENROLLING BY INVITATION
NCT05019027
PHASE4

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

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-01-31

Completion Date

2026-12-31

Last Updated

2025-10-23

Healthy Volunteers

No

Interventions

DRUG

Beta blocker

The intervention is a single-arm crossover withdrawal/reversal design (On vs Off) with 2 total periods, each period lasting between up to 6 weeks. During the On period, subjects will be on their beta blocker. During the Off period, their beta blockers will be down-titrated by 50% each week and until subsequently discontinued (or the lowest dose the subject can safely tolerate). Other Names: * acebutolol * atenolol * betaxolol * bisoprolol * carvedilol * labetalol * metoprolol succinate * metoprolol tartrate * nadolol * nebivolol * penbutolol * pindolol * propranolol

Locations (1)

Weill Cornell Medicine

New York, New York, United States