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Can a drug stop amyloid damage after a heart transplant?

NCT ID NCT05489523

Disease control Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether the drug tafamidis can safely stop the progression of ATTR amyloidosis in people who have already received a heart transplant. About 25 stable patients will take tafamidis daily for 12 months. Researchers will measure changes in blood protein levels, nerve function, and quality of life to see if the drug helps control the disease outside the heart.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tafamidis
What this could lead to
If it works, this could show that tafamidis safely prevents or slows amyloid buildup in nerves and the gut after a heart transplant.
What could go wrong
This is a small, early-phase study with only 25 people and no placebo group, so results may not apply broadly. Tafamidis may not work as well in transplant patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has received orthotopic heart transplantation for end-stage ATTRv or ATTRwt ≥12 months prior to screening. Concomitant hepatic and renal transplantation with adequate allograft function are included. * Has a stable immunosuppressive regimen and ≤ 10 mg of prednisone (or equivalent) at time of enrollment. * Has a Karnofsky performance status ≥ 70% Exclusion Criteria: * Has previously received inotersen within the past 180 days, patisiran within the past 90 days, tafamidis within the past 14 days, or diflunisal in the past 14 days. * Participating in a clinical trial for ATTR targeted therapies. * Has an estimated glomerular filtration rate (eGFR) ≤ 15 ml/min/1.73 m2 * Has known leptomeningeal or AL amyloidosis * Has active post-transplant lymphoproliferative disease * Excluding non-melanomatous skin cancers, has an active malignancy. * Has active infection with hepatitis B, hepatitis C, human immunodeficiency virus, or cytomegalovirus (CMV). For CMV, donor/ recipient exposure status and prior treated CMV disease on stable doses of antiviral therapies are not excluded. * Has cardiac allograft dysfunction defined by left ventricular ejection fraction (LVEF) \<50% by echocardiogram within the past 3 months * Has been treated for acute cellular or antibody mediated rejection in the past 3 months * Has criteria to meet International Society for Heart and Lung Transplantation standardized nomenclature for severe coronary allograft vasculopathy ("ISHLT CAV3")

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Conditions

The condition(s) this trial relates to.

familial amyloid neuropathy wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transthyretin cardiac amyloidosis

Contacts and locations

Locations

  • Cedars-Sinai

    Beverly Hills, California, 90211, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

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