Trial · NCT07897526
Superiority Assessment of Donor-derived Cell-FreE DNA ( Deoxyribonucleic Acid) for Cardiac Allograft REjection Monitoring
NCT07897526, Not applicable, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Superiority Assessment of Donor-derived Cell-FreE DNA ( Deoxyribonucleic Acid) for Cardiac Allograft REjection Monitoring. Trials, record NCT07897526. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07897526
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Superiority Assessment of Donor-derived Cell-FreE DNA ( Deoxyribonucleic Acid) for Cardiac Allograft REjection Monitoring
- NCT number
- NCT07897526
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 352 participants, estimated
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Heart Transplantation
- Interventions
- non-invasive strategy based of the analysis of circulating dd-cfDNA (AlloSeq cfDNA assay), control
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of all-cause mortality or listing for redo heart transplantation | 11 months after randomization | The incidence of all-cause mortality or listing for redo heart transplantation will be assessed from randomization through 11 months after randomization (12 months post-transplant). This is the first component of the hierarchical composite endpoint and will be assessed using clinical follow-up and medical records. |
| Primary | Incidence (%) of acute allograft dysfunction defined by an absolute decrease in left ventricular ejection fraction (LVEF) of ≥20 percentage points, assessed by transthoracic echocardiography | 11 months after randomization | The incidence of acute cardiac allograft dysfunction defined by an absolute decrease in left ventricular ejection fraction (LVEF) of ≥20 percentage points compared with the reference LVEF measured at the inclusion visit will be assessed from randomization through 11 months after randomization. LVEF will be measured by transthoracic echocardiography performed as part of routine clinical care. |
| Primary | Incidence (%) of acute allograft dysfunction defined by a several events | 11 months after randomization | Incidence (%) of acute allograft dysfunction defined by a several events : an absolute decrease in left ventricular ejection fraction (LVEF) of ≥20 percentage points, assessed by transthoracic echocardiography OR a proportional decrease in left ventricular ejection fraction (LVEF) of ≥25%, assessed by transthoracic echocardiography, OR by the occurence of hospitalization for acutely decompensated heart failure, assessed by clinical follow-up and medical records. The incidence of acute cardiac allograft dysfunction defined by a proportional decrease in left ventricular ejection fraction (LVEF) of ≥25% compared with the reference LVEF measured at the inclusion visit will be assessed from randomization through 11 months after randomization. LVEF will be measured by transthoracic echocardiography performed as part of routine clinical care. |
| Primary | Incidence (%) of post-procedural pericardial effusion requiring surgery, hospitalization, or an additional outpatient monitoring visit, assessed by transthoracic echocardiography | 11 months after randomization | The incidence of new post-procedural pericardial effusion requiring surgery, hospitalization, or an additional outpatient visit for monitoring will be assessed from randomization through 11 months after randomization. Pericardial effusion will be assessed by transthoracic echocardiography performed as part of routine clinical care and compared with the baseline echocardiographic assessment at the inclusion visit. |
| Primary | Incidence (%) of local venous puncture-site complications requiring surgery, emergency imaging, or hospitalization, assessed by clinical follow-up and medical records | 11 months after randomization | The incidence of local complications at the venous puncture site requiring surgery, emergency imaging, or hospitalization will be assessed from randomization through 11 months after randomization, based on clinical follow-up and review of medical records. |
| Primary | Mean change from baseline in total Hospital Anxiety and Depression Scale (HADS) score | 11 months after randomization | Symptoms of anxiety and depression will be assessed 11 months after randomization using the Hospital Anxiety and Depression Scale (HADS), a self-administered questionnaire. The outcome will be the change in total HADS score from baseline (inclusion visit) to 11 months after randomization. The total HADS score is calculated by summing the anxiety (HADS-A) and depression (HADS-D) subscale scores and ranges from 0 to 42 points. |
| Primary | Occurrence of Cardiac allograft vasculopathy | 11 months after randomization | Occurrence Cardiac allograft vasculopathy as assessed either by a coronary angiogram or by a coronary CT-scan (Computed Tomography scan) according to the local protocol (cardiac allograft vasculopathy ≥ grade 2 according to the ISHLT classification (International Society for Heart and Lung Transplantation) (grades range from 0 = no CAV to 3 = severe CAV) |
| Primary | Occurrence of Diagnosis of rejection | 11 months after randomization | Diagnosis of rejection according to international working formulations (EMB: Endomyocardial Biopsy) performed as part of routine clinical care, acute cellular rejection (ACR) ≥ 2R (ISHLT ACR score range: 0R (no cellular rejection) to 3R (severe cellular rejection)) and/or antibody-mediated rejection (AMR) ≥ pAMR1 (pAMR score range: pAMR0 = no evidence of antibody-mediated rejection to pAMR3 = severe antibody-mediated rejection), according to the ISHLT (International Society for Heart and Lung Transplantation) working formulations |
| Primary | Occurrence of Molecular cellular rejection | 11 months after randomization | Molecular cellular rejection score on protocol EMB (targeted molecular profiling using NanoString nCounter technology and Banff Human Organ Transplant Panel, a consensual targeted panel comprising 770 genes) |
| Secondary | Occurrence of Molecular antibody-mediated rejection | 11 months after randomization | Molecular antibody-mediated rejection score on protocol EMB (targeted molecular profiling using NanoString nCounter technology and Banff Human Organ Transplant Panel, a consensual targeted panel comprising 770 genes) |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07897526
GET https://conductscience.org/api/trials/v1/NCT07897526/registered?page=2