Trial · NCT05459181
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Allograft loss at 12-months post-transplant (safety) | 12 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | Incidence of Allograft loss at 24-months post-transplant (safety) | 24 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | Total number of acute rejection episodes (ACR >2R or AMR*) at 12-months post-transplant (safety) | 12 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | Total number of acute rejection episodes (ACR >2R or AMR*) at 24-months post-transplant (safety) | 24 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | EQ-5D survey performed at 12-months post-transplant to assess allograft function (safety) | 12 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | TTE imaging performed at 12-months post-transplant to assess allograft function (safety) | 12 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | EQ-5D survey performed at 24-months post-transplant to assess allograft function (safety) | 24 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | TTE imaging performed at 24-months post-transplant to assess allograft function (safety) | 24 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | Incidence of dnDSA formation at 12-months post-transplant (safety and efficacy) | 12 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | Incidence of dnDSA formation at 24-months post-transplant (safety and efficacy) | 24 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | Change in eGFR at 12-months post-transplant (efficacy) | 12 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | Change in eGFR at 24-months post-transplant (efficacy) | 24 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Primary | Total number of biopsies performed post-transplant, including both surveillance and clinically indicated biopsies (efficacy) | 24 months | Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization. |
| Secondary | Histological assessment of tissue biopsy with paired AlloSure dd-cfDNA and AlloMap GEP results (HeartCare) - performed both 'For Cause' and 'Surveillance' using standard biopsy assessment. | 6 months | Identify correlation between HeartCare and histopathological allograft rejection based on all clinical biopsies. |
| Secondary | Association between AlloSure dd-cfDNA and AlloMap GEP (HeartCare) results with successful immuno-optimization, longitudinal clinical/laboratory parameters (dnDSA), and histologic data (allograft rejection, CAV). | 24 months | Establish temporal relationships between HeartCare and allograft injury patterns such as dnDSA formation, allograft rejection and CAV. |
| Secondary | Data collection from patient medical record, to capture episodes of infection, viral PCR results, changes in immunosuppression and treatment of rejection, as well as all adverse advents. | 24 months | Assessment of all medical events throughout the duration of the study. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05459181/registered