Early Identification and Treatment of Rare Cardiomyopathy Cohorts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: diuretics, ACEIs/ARBs, beta blockers, positive inotropic drugs, MRAs, SGLT2i, retinoids, Close follow-up, early rehabilitation guidance.
- Who it may be relevant to
- Registry conditions: Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Metabolic Cardiomyopathy, Restrictive Cardiomyopathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Identification and Treatment of Rare Myocardium by Multimodal Imaging (EARLY-MYO-RARE)
Overview
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.
Interventions
- 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
Primary outcome measures
- The Heart Failure Incidence of Rare cardiomyopathy [Time frame: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]
Secondary outcome measures (4)
- Assessment of Changes in Cardiac Morphological Characteristics [Time frame: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]
- Quantitative Assessment of Changes in Cardiac Tissue Characteristics [Time frame: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]
- NT-proBNP [Time frame: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]
- VO2max [Time frame: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]
Eligibility criteria
Inclusion criteria
- Age 18-75 years old.
- Patients preliminarily diagnosed with heart failure and scheduled to receive drug therapy after being evaluated by cardiology departments.
- No history of structural heart disease, and the Framingham score \<5 (for patients with the Framingham score ≥5, coronary artery disease will be excluded by coronary 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Renji Hospital — Shanghai
Identifiers
NCT: NCT06794710 · RARE2024