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NCT Number: NCT06794710

Early Identification and Treatment of Rare Cardiomyopathy Cohorts

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy (HCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Restrictive Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dilated Cardiomyopathy (DCM) Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Laminopathies Metabolic Cardiomyopathy Restrictive Cardiomyopathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200030, China

Location contact

Zi Wang, MD,PHD

CONTACT

[email protected]

15000765160 ext. 15000765160

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Patients in this group will receive pharmacological treatment for heart failure.

Other names: pharmacological treatment for heart failure

Close follow-up

Behavioral

High risk patients receive close follow-up

early rehabilitation guidance

Behavioral

Early rehabilitation guidance such as cardiopulmonary exercise tests and cardiac rehabilitation therapy

Primary outcomes

  1. 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.

    The heart failure incidence will be diagnosed by identify biomarkers combined multimodal imaging with clinical data, blood samples, myocardial tissue samples.

Secondary outcomes

  1. 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.

    Changes in cardiac morphological characteristics will be assessed using multimodal imaging technologies, including:

    Outcome Measure 1: Echocardiography (Echo), assessing parameters such as: Left ventricular ejection fraction (LVEF) (measured as a percentage), Wall thickness (measured in millimeters), Left ventricular end-diastolic and end-systolic dimensions (measured in millimeters), Right ventricular size and function (measured in millimeters and percentage).

    Outcome Measure 2: Cardiac Magnetic Resonance Imaging (CMR), assessing parameters such as: Myocardial mass (measured in grams), Left ventricular volumes (end-diastolic and end-systolic, measured in milliliters), Left and right ventricular stroke volumes (measured in milliliters), Myocardial strain (measured as a percentage), Left ventricular myocardial fibrosis (measured as a percentage of the myocardium).

  2. 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.

    CMR T1 mapping-derived extracellular volumes (ECV) will be used to detect changes in the myocardium interstitial matrix. ECV will be calculated according to the ECV formula consist of T1 mapping value. CMR T2 mapping value will be used to depict changes in the myocardial edema.

  3. 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.

    Blood test

  4. 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.

    Cardiopulmonary exercise test (CPET)

Study contacts

Contact information is provided by the study sponsor or research team.

Meng Jiang, MD, PhD

CONTACT

[email protected]

13788912766 ext. 13788912766

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Acronym: EARLY-MYO-RARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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