Trial · NCT07886489
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Association between dd-cfDNA level and acute allograft rejection (TCR and AMR) in the first year after transplantation, which will be evaluated using a linear mixed model and reported as the model estimate for the fixed effect (allograft rejection) | From baseline to one year follow up | |
| Secondary | Association between dd-cfDNA level and acute allograft rejection in the 3rd, 5th and 10th year after transplantation implementing linear mixed models and reported as the model estimate for the fixed effect (allograft rejection) | From baseline to 10 year follow up | |
| Secondary | The area under the ROC curve (AUROC) depicting the performance of dd-cfDNA to distinguish between acute allograft rejection or no rejection in the 1st, 3rd, 5th and 10th year after transplantation. | From baseline to 10 ten year follow up | |
| Secondary | The sensitivity and positive predictive value (PPV) of dd-cfDNA as a biomarker of allograft rejection, i.e., the proportion of positive results (increased dd-cfDNA) that are true positive (developed rejection) after 1, 3, 5 and 10 years | Baseline to 10 year follow up | |
| Secondary | The specificity and negative predictive value (NPV) of dd-cfDNA as a biomarker of acute allograft rejection, i.e., the proportion of negative results (decreased/no change in dd-cfDNA) that are true negative (no rejection) after 1, 3, 5 and 10 years | Baseline to 10 year follow up | |
| Secondary | Change in the fraction of dd-cfDNA (dd-cfDNA kinetics) in patients without allograft rejection in the first six weeks after transplantation | Baseline to 6 weeks afters transplantation | |
| Secondary | Correlation between dd-cfDNA level, clinical findings (GLS, biopsy results, etc.) and patient characteristics | Baseline to 1, 3, 5, and 10 year follow up | |
| Other | AUROC depicting the performance of current available biomarkers, including TnT to distinguish between acute allograft rejection or no rejection, and compare with AUROC statistics of dd-cfDNA | Baseline to 1, 3, 5, and 10 year follow up | |
| Other | Allograft dysfunction, i.e., frequency of patients developing moderate to severe CAV (CAV score ≥2) after year 1, 2, 5 and 10 of transplantation stratified by the number and type of rejection | Baseline to 1, 3, 5, and 10 year follow up | |
| Other | Correlation between dd-cfDNA levels, CAV progression and overall mortality during the 10-year project period | Baseline to 10 year follow up | |
| Other | The frequency of patients developing HLA antibodies over the 10-year project and the correlation to overall mortality stratified by type of donor-specific HLA antibodies and strengths | Baseline to 1, 3, 5, and 10 year follow up | |
| Other | Correlation between HLA antibodies (type and strength), dd-cfDNA level and overall mortality | Baseline to 1, 3, 5, and 10 year follow up | |
| Other | Patient survival 10 years after heart transplantation | Baseline to 5 and 10 year follow up |
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/NCT07886489/registered