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CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine

NCT06158698 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-20

No results posted yet for this study

Summary

Two-parallel groups randomized, single-blinded, multi-center phase III controlled trial in patients with chronic inflammatory cardiomyopathy to assess the efficacy of colchicine and associated prospective registry to assess the prognostic value of positive genetic testing in this population.

Conditions

Interventions

OTHER

Placebo

Placebo 1 mg daily (or 0.5 mg daily il weight \<70 kg) from randomization for 180 days (6 months)

DRUG

Colchicine

Colchicine 1 mg daily (or 0.5 mg daily il weight \<70 kg) from randomization for 180 days (6 months)

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • University of Milano Bicocca

    collaborator OTHER

  • Niguarda Hospital

    lead OTHER

Principal Investigators

  • Enrico Ammirati, MD, PhD · ASST Grande Ospedale Metropolitano Niguarda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2026-05-02
Completion
2028-05-02

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06158698 on ClinicalTrials.gov