Trial · NCT06158698
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
NCT06158698, Phase 3, Recruiting, Niguarda Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine. Trials, record NCT06158698. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06158698
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
- NCT number
- NCT06158698
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Niguarda Hospital
- Conditions
- Cardiomyopathies, Myocarditis, Inflammatory Cardiomyopathy, Heart Failure, Ventricular Arrythmia
- Interventions
- Colchicine, Placebo
- First posted
- 2023-12-06
- Last updated
- 2026-04-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Papers11
The papers the trial lists on ClinicalTrials.gov.
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/NCT06158698
GET https://conductscience.org/api/trials/v1/NCT06158698/registered