Beta-Blocker Tapering for Cardiac Amyloidosis

Palo Alto (17 mi)

Overseen byParag Goyal, MD, MSc

Age: 65+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Prior Safety Data

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for ambulatory adults aged 65 or older with TTR-cardiac amyloidosis, confirmed by specific tests, who are currently taking beta-blockers. It's not suitable for those with a life expectancy under 6 months, recent medication changes, severe heart issues in the past 3 years, certain mental health conditions, hospitalization within the last month, or any other condition that makes them unsuitable as per the investigator.

Inclusion Criteria

I am 65 or older and have TTR-cardiac amyloidosis confirmed by a scan or biopsy.

I am currently taking a beta-blocker medication.

Exclusion Criteria

I was in the hospital within the last 30 days.

My heart cannot pump blood effectively anymore.

I experience chest pain.

I was hospitalized for a fast heartbeat due to atrial arrhythmia in the last year.

Treatment Details

The study is testing whether patients with cardiac amyloidosis feel better without their usual beta-blocker medication. Participants will alternate between periods of taking and not taking their beta-blocker over two spans of up to six weeks each. The process includes interviews and stakeholder engagement to assess the approach.

1Treatment groups

Experimental Treatment

Group I: On-Off SequenceExperimental Treatment1 Intervention

This arm will follow an On-Off sequence. This is the only arm in the study. Subjects will begin in the On phase (Period 1), maintaining their beta-blocker dosage as previously prescribed to the subjects by their physician. Subjects will then continue to the Off phase (Period 2) where they will down-titrate their beta-blocker by 50% each week until they are completely off the drug for a total of two weeks. At the end of Period 2, the subjects will have their End of Intervention visit in which they will determine if they would like to continue or discontinue their beta-blockers for the foreseeable future.