Early Identification and Treatment of Rare Cardiomyopathy Cohorts

NCT ID: NCT06794710

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Hypertrophic Cardiomyopathy (HCM) Dilated Cardiomyopathy (DCM) Metabolic Cardiomyopathy Restrictive Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Non-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 inhibitors (SGLT2i), and retinoids.

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

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

Model-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, aldosterone receptor blockers (MRA), sodium glucose cotransporter 2 inhibitors (SGLT2i), and retinoids.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Close follow-up

Intervention Type BEHAVIORAL

High risk patients receive close follow-up

early rehabilitation guidance

Intervention Type BEHAVIORAL

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

Interventions

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

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

Intervention Type DRUG

Close follow-up

High risk patients receive close follow-up

Intervention Type BEHAVIORAL

early rehabilitation guidance

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

Intervention Type BEHAVIORAL

Other Intervention Names

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pharmacological treatment for heart failure

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meng Jiang, MD, PhD

Role: STUDY_CHAIR

RenJi Hospital, School of Medicine, Shanghai Jiantong University

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Meng Jiang, MD, PhD

Role: CONTACT

13788912766 ext. 13788912766

Facility Contacts

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Zi Wang, MD,PHD

Role: primary

15000765160 ext. 15000765160

Other Identifiers

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RARE2024

Identifier Type: -

Identifier Source: org_study_id

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