Do tiny coronary blood vessel problems affect outcomes in dilated cardiomyopathy?
Prognostic Values of Coronary Microvascular Dysfunction in Patients With Dilated Cardiomyopathy
Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT07293338
This project will test whether coronary microvascular dysfunction changes long-term outcomes for people with dilated cardiomyopathy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07293338 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll adults with dilated cardiomyopathy, reduced left ventricular ejection fraction, and no significant epicardial coronary stenosis. Coronary angiography performed for clinical care will be used to characterize coronary microvascular function. Participants will be followed over time for clinical outcomes such as heart failure progression, hospitalizations, biomarkers, and death. The goal is to link baseline microvascular findings to long-term prognosis in this population.
Who should consider this trial
Good fit: Adults with confirmed dilated cardiomyopathy (enlarged LV by echo), clinical heart failure with BNP ≥35 pg/mL or NT-proBNP ≥125 pg/mL, LVEF <45%, and coronary angiography showing ≤50% stenosis in all major epicardial vessels.
Not a fit: Patients with significant coronary artery disease, hypertensive heart disease, rheumatic valvular disease, myocarditis, other secondary cardiomyopathies, or poor angiographic image quality are not expected to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help identify patients at higher risk who may need closer monitoring or targeted therapies.
How similar studies have performed: Some studies in other cardiac conditions have linked microvascular dysfunction to worse outcomes, but its prognostic role specifically in dilated cardiomyopathy is not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Dilated cardiomyopathy comfirmed by echocardiography: LVDd \> 55 mm in men or \> 50 mm in women. * Clinically evident congestive heart failure: Compatible symptoms and signs, and BNP ≥ 35 pg/mL or NT-proBNP ≥ 125 pg/mL, and LV systolic dysfunction defined by LVEF \< 45 %. * Coronary angiography showing stenosis ≤ 50 % in all major epicardial vessels. Exclusion Criteria: * Patients with coronary artery disease, hypertensive heart disease, rheumatic valvular heart disease, myocarditis, and other secondary cardiomyopathies. * poor angiographic image quality
Where this trial is running
Hangzhou, Zhejiang
- The second affiliated hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Jun Jiang, MD
- Email: 21918219@zju.edu.cn
- Phone: +86 15657125311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dilated Cardiomyopathy