Trial · NCT06158698
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 | Patients alive and free of any worsening features (clinical, arrhythmic burden and imaging outcome) AND that show at least one of the signs of improvements (IMAGING or ARRHYTMIC improvements). | 6 months from randomization | Clinical worsening (at least one of the following): 1. cardiac death 2. hospitalization for worsening HF or arrhythmic events, 3. Sustained ventricular tachycardia (SVT). Worsening arrhythmic burden: 1. PVC burden increase of 50% on ECG ambulatory monitoring 2. Increase in NSVT of 30% compared with baseline 3. Any SVT. |
| Primary | Worsening imaging outcomes | 6 months from randomization | 1. Proportion of patients with LVEF reduction \>10%on echo/CMRI, 2. Proportion of patients with new areas of edema on CMRI or FDG-PET associated with an increase in the edema in the inflammatory lesion identified on baseline CMRI or FDG-PET. Improvement of imaging outcome: 1. Proportion of patients with a reduction in edema on CMRI or FDG without new areas of edema AND normal high sensitivity troponin. 2. Proportion of patients with disappearance of edema on CMRI OR NO FDG uptake on PET Improvement of arrhythmic outcome: 1\. Improvement of ARRHYTHMIC burden. Proportion of patients with a PVC burden reduction of 70% on the ECG ambulatory monitoring and no NSVT/SVT. |
| Secondary | LVEF change on echocardiogram. | 6 months from randomization | Absolute change at 6 months from randomization of the LVEF on echocardiogram. Patients not performing echocardiography due to death, heart transplantation (HTx) will be counted as -10 point in the LVEF. |
| Secondary | LVEF change on CMRI | 6 months from randomization | Absolute change at 6 months from randomization of the LVEF on CMRI when available. Patients not performing the CMRI due to death, HTx, LVAD implantation or device implantation after randomization will be counted as -10 point in the LVEF. |
| Secondary | Evidence of dysfunction and/or dilation on CMRI | 6 months from randomization | Proportion of patients with LVEF\<55% AND/OR LV dilation on 6-month CMRI (CMRI clips will be centrally reviewed) or not performing the CMRI due to death, HTx, LVAD implantation or device implantation after randomization (i.e. ICD). |
| Secondary | Clinical secondary endpoints | 6 months from randomization | Composite endpoint: (1) all-cause death or (2) HTx or (3) LVAD implantation, or (5) first rehospitalization due to HF or VA, or advanced atrioventricular (AV) block. |
| Secondary | Mortality | 6 months from randomization | All-cause deaths |
| Secondary | Time to HF or arrhythmic events | 6 months from randomization | Time to hospitalization for HF/VA or advanced AV block |
| Secondary | Changes on ambulatory ECG monitoring | 6 months from randomization | Composite endpoint of NSVT OR increased burden of PVCs (\>5%) on 24-hour ECG ambulatory monitoring, performed at 6- months |
| Secondary | Changes in Quality of life | 6 months from randomization | Changes in quality of life at 6 months follow up compared with baseline using 2 different questionnaires: the EoQ-5D-5L and KCCQ (CSS and OSS) |
| Secondary | Need for immunosuppression | 6 months from randomization | Need to initiate an immunosuppressive drug |
| Other | The primary aim of the REGISTRY is the proportion of patients with MCGV(+) Infl-CMP versus MCGV(-) Infl-CMP with more primary endpoints | Minimum follow up at 6 months | We will measure the outcome of the patients in the registry as described in the TRIAL at the end of a minimum follow-up of 6 months. The co-primary aim of the registry will be to the identify baseline variables that are independently associated with the above-mentioned 6-month endpoints. The patients who enter the registry are expected to follow an even longer follow-up of 2 The Registry endpoints pooling together patients included in the trial and registry. |
| Other | Differences in the results of in-vitro experiments between MCGV(+) vs. MCGV(-) Infl-CMP patients and between MCGV(+) Infl-CMP patients and family members of the probands with the negative cardiac phenotype (FMPNCP) | Minimum follow up at 6 months | We will compare in-vitro experiments between MCGV(+) vs. Infl-CMP versus MCGV(-) Infl-CMP patients and between MCGV(+) Infl-CMP patients and family members of the probands with the negative cardiac phenotype (FMPNCP). Samples for the experiments will be from patients included in the trial and registry. |
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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