NCT07293338

Brief Summary

The goal of this observational study is to learn about the long-term prognostic of coronary microvascular dysfuction in Patients with Dilated Cardiomyopathy. The main question it aims to answer is: Does the coronary microvascular dysfunction impact the outcomes in Patients with Dilated Cardiomyopathy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

November 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

January 6, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 19, 2025

Status Verified

October 1, 2025

Enrollment Period

1.8 years

First QC Date

November 18, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    A composite of cardiac death, hospitalization for heart failure, heart transplantation, and device implantation

    At 5-year follow-up

Study Arms (2)

Coronary microvascular dysfunction

Procedure: coronary angiography

Non-Coronary microvascular dysfunction

Procedure: coronary angiography

Interventions

Patients should undergo coronary angiography to confirm the absence of significant coronary stenosis. Angio-IMR was calculated based on the angiography.

Coronary microvascular dysfunctionNon-Coronary microvascular dysfunction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged ≥ 18 years with angiography-confirmed absence of coronary stenosis and a definitive diagnosis of dilated cardiomyopathy.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with coronary artery disease, hypertensive heart disease, rheumatic valvular heart disease, myocarditis, and other secondary cardiomyopathies.
  • poor angiographic image quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 19, 2025

Study Start

January 6, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 19, 2025

Record last verified: 2025-10

Locations