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Clinical Trial NCT06794710 (EARLY-MYO-RARE) for Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Metabolic Cardiomyopathy, Restrictive Cardiomyopathy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Early Identification and Treatment of Rare Cardiomyopathy Cohorts (EARLY-MYO-RARE) 300 Biomarker-Driven Prevention
Clinical Trial NCT06794710 (EARLY-MYO-RARE) is an interventional study for Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Metabolic Cardiomyopathy, Restrictive Cardiomyopathy and is currently not yet recruiting. Enrollment is planned to begin on 1 February 2025 and continue until the study accrues 300 participants. Led by RenJi Hospital, this study is expected to complete by 30 September 2027. The latest data from ClinicalTrials.gov was last updated on 27 January 2025.
Brief 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 c...Show More
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 cardiom...Show More
Official Title
Early Identification and Treatment of Rare Myocardium by Multimodal Imaging (EARLY-MYO-RARE)
Conditions
Hypertrophic Cardiomyopathy (HCM)Dilated Cardiomyopathy (DCM)Metabolic CardiomyopathyRestrictive CardiomyopathyOther Study IDs
- EARLY-MYO-RARE
- RARE2024
NCT ID Number
Start Date (Actual)
2025-02-01
Last Update Posted
2025-01-27
Completion Date (Estimated)
2027-09-30
Enrollment (Estimated)
300
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
rare cardiomyopathy, cardiac multimodal imaging, myocardial impairment
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Placebo ComparatorNon-model-based prediction group Heart Faliure Patient Group without diagnosed by multimodal imaging, and they will receive a traditional pharmacological treatment for heart failure.Traditional anti heart failure drug therapy included diuretics, angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor antagonists (ARBs), beta blockers, positive inotropic drugs, aldosterone receptor blockers (MRA), sodium glucose cotransporter 2 inhibito...Show More | diuretics, ACEIs/ARBs, beta blockers, positive inotropic drugs, MRAs, SGLT2i, retinoids Patients in this group will receive pharmacological treatment for heart failure. |
ExperimentalModel-guided optimized treatment Patients with heart failure who were diagnosed in Rare Cardiomypathy by multimodal imaging. And They will receive Close follow-up, intensified pharmacological treatment for heart failure, and early rehabilitation guidance. Traditional anti heart failure drug therapy: diuretics, angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor antagonists (ARBs), beta blockers, positive inotropic drugs, aldosteron...Show More | diuretics, ACEIs/ARBs, beta blockers, positive inotropic drugs, MRAs, SGLT2i, retinoids Patients in this group will receive pharmacological treatment for heart failure. Close follow-up High risk patients receive close follow-up early rehabilitation guidance Early rehabilitation guidance such as cardiopulmonary exercise tests and cardiac rehabilitation therapy |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | 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 | 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. | 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 | Blood test | 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 | Cardiopulmonary exercise test (CPET) | 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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
RenJi HospitalStudy Central Contact
Contact: Meng Jiang, MD, PhD, 13788912766, [email protected]
1 Study Locations in 1 Countries
Shanghai Municipality
Renji Hospital, Shanghai, Shanghai Municipality, 200030, China
Zi Wang, MD,PHD, Contact, 15000765160, [email protected]