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Early Identification and Treatment of Rare Cardiomyopathy Cohorts

ConditionsHypertrophic Cardiomyopathy (HCM)Dilated Cardiomyopathy (DCM)Metabolic CardiomyopathyRestrictive Cardiomyopathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    Patients in this group will receive 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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Non-model-based prediction groupPlacebo comparator 1 intervention
Group B: Model-guided optimized treatmentExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

The Heart Failure Incidence of Rare cardiomyopathy

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

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 outcomes

1

Assessment of Changes in Cardiac Morphological Characteristics

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).

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.
2

Quantitative Assessment of Changes in Cardiac Tissue Characteristics

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.

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.
3

NT-proBNP

Blood test

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.
4

VO2max

Cardiopulmonary exercise test (CPET)

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: