Early Identification and Treatment of Rare Cardiomyopathy Cohorts

Last updated: January 21, 2025
Sponsor: RenJi Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Heart Defect

Circulation Disorders

Treatment

Close follow-up

early rehabilitation guidance

diuretics, ACEIs/ARBs, beta blockers, positive inotropic drugs, MRAs, SGLT2i, retinoids

Clinical Study ID

NCT06794710
RARE2024
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-75 years old.

  • Patients preliminarily diagnosed with heart failure and scheduled to receive drugtherapy after being evaluated by cardiology departments.

  • No history of structural heart disease, and the Framingham score <5 (forpatients with the Framingham score ≥5, coronary artery disease will be excluded bycoronary angiography/coronary CT/exercise platelet).

  • Creatinine clearance ≥50ml/min (Cockcroft-Gault formula).

  • LVEF ≥50% assessed by Echocardiography.

  • QT interval < 470 ms.

  • Providing written informed consent.

Exclusion

Exclusion Criteria:

  • Presence of acute/chronic renal impairment (GFR <50/ml/min/1.73m2).

  • History of cardiovascular disease such as confirmed coronary artery disease,valvular disease, cardiomyopathy, congenital heart disease, and heart failure.

  • Presence of contraindications to CMR.

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Close follow-up
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
September 30, 2027

Study 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.

Connect with a study center

  • Renji Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

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