Observational Study of Natural History of BAG3 Gene Mutation-Associated Dilated Cardiomyopathy in Chinese Adults

Sponsor
AstraZeneca
Study ID
NCT07646600
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Observational, None intervention — OTHER
    Observational, None intervention

Study Details

This is a multicentre, prospective cohort study designed to elucidate the natural history of dilated cardiomyopathy (DCM) associated with specific gene mutations in Chinese patients. By establishing a cohort of patients with inherited cardiomyopathy, the study will collect comprehensive data, including demographic characteristics, disease history, clinical features, prior treatments, current treatment patterns, clinical outcomes, and patient-reported outcomes (PROs). The objective is to describe the disease profile, current diagnostic and therapeutic landscape, clinical progression, and prognosis of this specific patient population in China. The data generated will provide a foundational basis for deepening the understanding of disease progression, identifying unmet clinical needs, and exploring potential surrogate endpoints for future clinical trials in drug development. The study plans to enroll 10 eligible patients with BCL-2-associated athanogene 3 (BAG3)-associated inherited DCM from 3 research sites across China.

Key Dates

First listed
Jun 15, 2026
Start date
Jun 29, 2026
Status verified
Jun 2026
Primary completion
Jun 29, 2029
Completion
Jun 29, 2029

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: patients with BAG3 DCM
    Approximately 10 patients with BAG3 DCM will be enrolled from 3 research sites in China. Comprehensive clinical data, including demographic characteristics, medical history, clinical manifestations, treatment records, clinical outcomes, and PROs, will be collected.

Primary Outcome Measure

changes in cardiac imaging parameters, left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS) [ Time Frame: Baseline (at Day 1 post-enrollment), 12 months and 24 months ]

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