Trial · NCT07897526
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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) |
| Secondary | Area under the curve of the targeted calcineurins inhibitors doses (residual concentration) | 1, 2, 5, 8 and 11 month after randomization | Exposure to immunosuppressive drugs as assessed by the area under the curve of the percentage of the targeted calcineurins inhibitors doses (percentage of cyclosporine or tacrolimus trough level compared to the reference targets according to international guidelines) |
| Secondary | Rate of infectious complications | 11 months after randomization | Rate of infectious complications as defined by any symptomatic documented bacterial, viral, fungal, or parasitic infection requiring a specific treatment and/or a minimization of immunosuppression. |
| Secondary | Number of endomyocardial biopsies | 11 months after randomization | Number of endomyocardial biopsies performed during 11 months post randomization, |
| Secondary | incremental cost effectiveness ratio (ICER) | 11 months after randomization | The incremental cost-effectiveness ratio (ICER) will be calculated as the difference in mean costs between the experimental and control groups divided by the difference in effectiveness, with effectiveness measured using the prespecified primary endpoint. The ICER will be expressed as cost per unit of effectiveness gained |
| Secondary | Incremental cost-utility ratio (ICUR) | 11 months after randomization | The incremental cost-utility ratio (ICUR) will be calculated as the difference in mean costs between the experimental and control groups divided by the difference in quality-adjusted life years (QALYs) gained. The ICUR will be expressed as cost per QALY gained. |
| Secondary | Budget impact of the non-invasive dd-cfDNA-based strategy compared with control strategy from the French healthcare system | 11 months after randomization | Budget impact analysis (BIA) conducted according to ISPOR good practice guidelines and French HAS methodological recommendations. The incremental budget impact will be estimated by comparing two scenarios: a world in which the non invasive dd-cfDNA-based strategy is implemented and a counterfactual world without this strategy based on the eligible population in France and assumptions on market uptake. Data on resource use, costs and cost offsets will be derived from the SAFE-CARE trial, supplemented with estimates published in the relevant literature. Results will be expressed in euros (€) as the annual and cumulative incremental budget impact. |
| Secondary | Mean of total Hospital Anxiety and Depression Scale (HADS) score | 2, 5, 8 and 11 months after randomization | Anxiety and depression symptoms will be assessed using the total score of the Hospital Anxiety and Depression Scale (HADS), a self-administered questionnaire. The total HADS score ranges from 0 to 42 points, with higher scores indicating greater symptoms of anxiety and depression. The mean total HADS score will be reported at 2, 5, 8, and 11 months after randomization. |
| Secondary | Mean score of Anxiety and Depression | 2, 5, 8 and 11 months after randomization | Anxiety and Depression score assessed by HAD (Hospital Anxiety and Depression scale) questionnaire (Scores range from 0 to 21 for each subscale, with higher scores "21" = more severe anxiety or depression; 0 = no symptoms): mean scores and proportion of patients with definite symptomatology of anxiety and depression (overall score ≥ 11 points) |
| Secondary | Proportion of patients with clinically relevant anxiety and depression symptoms | 2, 5, 8 and 11 months after randomization | The proportion of patients with clinically relevant symptoms of anxiety and depression will be assessed using the total Hospital Anxiety and Depression Scale (HADS) score. Clinically relevant symptomatology will be defined as a total HADS score ≥11 points. |
| Secondary | Mean score of EQ-5D-5L health status | 2, 5, 8 and 11 months after randomization | Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L assesses five dimensions of health, each rated from 1 (no problems) to 5 (extreme problems). The health status profile will be reported at 2, 5, 8, and 11 months after randomization. |
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.
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