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Beta-Blocker Tapering for Cardiac Amyloidosis

Phase 4

Recruiting

Led By Parag Goyal, MD, MSc

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ambulatory adults age ≥65 years with TTR-cardiac amyloidosis (confirmed by PYP scan or biopsy)

Taking beta-blocker

Must not have

Hospitalized in past 30 days

Decompensated heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; weekly for up to 12 weeks; end of period 1 (week 2, 3, 4, 5, or 6), period 2 (week 8, 9, 10, 11, or 12)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test how well N-of-1 trials work for slowly taking patients off of beta-blockers while monitoring their health.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this trial involves stopping a drug rather than starting one, potential side effects when off beta-blockers may include increased heart rate and blood pressure fluctuations. Each patient's experience may vary based on their individual health profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am currently taking a beta-blocker medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was in the hospital within the last 30 days.

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My heart cannot pump blood effectively anymore.

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I experience chest pain.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; weekly for up to 12 weeks; end of period 1 (week 2, 3, 4, 5, or 6), period 2 (week 8, 9, 10, 11, or 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; weekly for up to 12 weeks; end of period 1 (week 2, 3, 4, 5, or 6), period 2 (week 8, 9, 10, 11, or 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; weekly for up to 12 weeks; end of period 1 (week 2, 3, 4, 5, or 6), period 2 (week 8, 9, 10, 11, or 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The change in exercise capacity when on beta-blocker versus when off beta-blocker, as measured by peak oxygen consumption (VO2) during Cardiopulmonary Exercise Test (CPET).

The change in patient-reported health status when on beta-blocker versus when off beta-blocker, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12).

The change in patient-reported quality of life when on beta-blocker versus when off beta-blocker, as measured by the EuroQol-5d Visual Analogue Scale.

Secondary study objectives

Change in patient-reported quality of life when on beta-blocker, as measured by the Patient-Reported Outcome Measurement Information System-29 (PROMIS-29)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Beta blocker

2015

Completed Phase 4

~420

0 / 6Eligibility criteria met