Beta-Blocker Tapering for Cardiac Amyloidosis

Overseen By Princess Osma, BA

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must be taking: Beta-blockers

Disqualifiers: Angina, Acute coronary syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

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.

Research Team

Parag Goyal, MD, MSc

Principal Investigator

Weill Medical College of Cornell University

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

Estimated life expectancy <6 months

I was in the hospital within the last 30 days.

My heart cannot pump blood effectively anymore.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

On Phase (Period 1)

Participants are on their beta-blocker (or the highest dose they can safely tolerate) as previously prescribed by their physician

Up to 6 weeks

Weekly visits for monitoring

Off Phase (Period 2)

Participants down-titrate their beta-blocker by 50% each week until they are completely off the drug (or the lowest dose they can safely tolerate)

Up to 6 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Beta blocker

Trial Overview 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.

Participant Groups

Group I: On-Off Sequence Experimental Treatment 1 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), where they will be on their beta-blocker (or the highest dose they can safely tolerate) 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 (or the lowest dose they can safely tolerate) for a total of two weeks. At the end of Period 2, the subjects will have their End of Intervention visit to determine if they would like to continue or discontinue their beta-blockers for the foreseeable future.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

U.S. Deprescribing Research Network

Collaborator

Trials

1

Recruited

20+