NCT06794710

Early Identification and Treatment of Rare Cardiomyopathy Cohorts

Early Identification and Treatment of Rare Myocardium by Multimodal Imaging (EARLY-MYO-RARE)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to further develop an imaging-guided cohort of rare cardiomyopathies based on the existing database. The investigators will standardize the construction of a cohort that integrates a clinical data repository, serum biobank, myocardial tissue bank, and imaging database. In the current cohort, the investigators will systematically screen for biomarkers indicative of pathological changes in challenging cardiomyopathies. Multidimensional data will be integrated to establish and optimize a heart failure risk assessment model, which will then be validated in a prospective cohort. The effectiveness of the model in assessing different risk groups will be evaluated, with the goal of achieving precise prevention of heart failure from the source.

Detailed description

To answer what are the key clinical questions of patients with rare cardiomyopathies resulted in high risk of adverse outcomes and requiring intensified treatment, this study will systematically refine and expand the cohort. This study will combine multimodal imaging with clinical data, blood samples, myocardial tissue samples to retrospectively identify biomarkers associated with pathological changes in rare cardiomyopathies; thereby to integrate multi-dimensional data to develop and validate a prognostic risk assessment model and evaluate the effectiveness of treatments guided through prospective randomized controlled trials by this model. Ultimately, this study aims to offer an integrated solution for the diagnosis and treatment of rare cardiomyopathies.

Conditions

• Hypertrophic Cardiomyopathy (HCM)
• Dilated Cardiomyopathy (DCM)
• Metabolic Cardiomyopathy
• Restrictive Cardiomyopathy

Interventions

Type	Name	Description
DRUG	diuretics, ACEIs/ARBs, beta blockers, positive inotropic drugs, MRAs, SGLT2i, retinoids	Patients in this group will receive pharmacological treatment for heart failure.
BEHAVIORAL	Close follow-up	High risk patients receive close follow-up
BEHAVIORAL	early rehabilitation guidance	Early rehabilitation guidance such as cardiopulmonary exercise tests and cardiac rehabilitation therapy

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-05-30
• Completion: 2027-09-30
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

1 site across 1 country: China