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Safety, Efficacy, and Pharmacokinetics of Tafamidis in Patients With Transthyretin-mediated Amyloidosis Post Orthotopic Heart Transplantation

StatusActive, Not Recruiting
PhasePhase 4
Started2023-05-01
View on ClinicalTrials.gov ↗

Amendment history

2026-06-02
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations, IPDSharing v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-05-01→2027-05-31
Completion date2026-05-01→2027-05-31
Study sitesdetails revised at 4 of 4 sites
2025-08-29
minor
Study Status, Contacts/Locations v9
Study sites3→4
2025-02-12
minor
Study Status, IPDSharing v8
Primary completion date2025-04-30→2026-05-01
Completion date2025-04-30→2026-05-01
2024-11-19
minor
Study Status, Contacts/Locations v7
Study sites2→3
2024-07-24
minor
Study Status, Outcome Measures, Contacts/Locations v6
Study sites1→2
Secondary endpoints7 to 5 entries
Serial change from baseline in Rasch-built Overall Disability Scale (R-ODS) at 12 months Serial change from baseline in modified body mass index (mBMI) at 12 months
Show 5 earlier versions
2024-07-02
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2023-11-16
minor
Study Status v4
Re-verified, no change to tracked fields
2023-04-23
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-03-30→2025-04-30
Completion date2025-03-30→2025-04-30
Start date2023-03-15→2023-05-01
Study sitesdetails revised at 1 of 1 site
2023-01-27
minor
Study Status v2
Primary completion date2024-09-30→2025-03-30
Completion date2024-09-30→2025-03-30
Start date2022-12-15→2023-03-15
2022-10-31
minor
Study Status v1
Start date2022-10-01→2022-12-15
2022-08-02
minor
Original filing
Transthyretin cardiac amyloidosis (ATTR-CA) is a relentlessly progressive disease that can progress to end stage heart failure, at which point recently approved transthyretin production silencing or structure stabilizing therapies provide no clinical benefit. For well-selected individuals, heart transplantation is an excellent therapeutic option to improve survival. Historically, concomitant liver transplantation has been used to halt the progression of non-cardiac transthyretin amyloidosis (ATTR) manifestations, especially for individuals with TTR genotypes associated with significant neuropathy. However, despite this, patients continue to experience progressive non-cardiac manifestations, particularly gastrointestinal and neuropathic, which can have a substantial influence on post-heart transplantation morbidity. Concomitant liver transplantation is also associated with substantial morbidity and its future therapeutic role is questionable with recently established therapies for ATTR. Therefore, there is a clear unmet need to determine the utility and safety of ATTR targeted therapies for patients with recent heart transplantation for end-stage ATTR-CA. The central hypothesis of this proposal is that in patients who have received a heart transplantation for end-stage ATTR-CA, tafamidis therapy will be efficacious and well-tolerated. We aim to determine the safety and efficacy of tafamidis in stable patients who have undergone heart or combined heart/liver transplantation for ATTR (wild-type or variant) cardiac amyloidosis. The proposed study will be a single-arm intervention clinical trial with tafamidis. Because of the efficacy of tafamidis for both variant ATTR-CA and wild-type ATTR-CA, there is no clinical equipoise for an inactive-comparator placebo arm. The primary endpoint of this study will be serial change in plasma transthyretin (TTR) levels from baseline to 12 months at 3-month intervals. The secondary endpoints of this study will include serial changes in neuropathy assessments, modified body mass indices, incident transplant-specific adverse events, and pharmacokinetics of tafamidis. Observations from this study will establish the role of tafamidis use for the management of ATTR in patients after transplantation for end-stage ATTR-CA.
Trial Details
NCT Number NCT05489523
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Transthyretin Cardiac Amyloidosis
Enrollment 25 participants
Start Date 2023-05-01
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-04