Evaluating coronary microvascular dysfunction in heart failure patients
Official title: The Role of Coronary Microvascular Dysfunction in Improving Left Ventricular Systolic Function Using Registry for Evaluation of Factors associatEd With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology (REFERENCE).
Run by Samsung Medical Center · NCT06243653 · Data updated 2026-11-12
This study is trying to see if problems with tiny blood vessels in the heart affect how well people with heart failure can improve their heart function after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | August 9, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | February 6, 2024 |
| Trial ID | NCT06243653 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 19 and older with symptoms of heart failure and a left ventricular ejection fraction of 40% or less due to non-ischemic causes.
✕Probably not a fit
Patients with significant coronary artery stenosis, those scheduled for cardiac replacement therapy, or those with other specific cardiac conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the incidence of coronary microvascular dysfunction (CMD) and its prognostic implications for improving left ventricular function in patients diagnosed with heart failure with reduced ejection fraction (HFrEF) due to non-ischemic causes. The study will utilize invasive physiological assessments to evaluate CMD, specifically measuring coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR). By understanding the relationship between CMD and left ventricular function improvement after guideline-directed medical treatment, the study aims to provide insights into the management of HFrEF patients. The findings could help identify patients at risk for irreversible myocardial damage.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for heart failure patients, potentially improving their heart function and overall prognosis.
How similar studies have gone: While there is limited data on this specific relationship, similar studies have explored CMD in heart failure, indicating potential for meaningful insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * a) Subject must be at least 19 years of age. b) Subject with symptoms or signs of HF (NYHA ≥2 dyspnea) and reduced ejection fraction (LVEF ≤ 40%) c) Subject who clinically need coronary angiography d) Subject who can voluntarily sign informed consent form Exclusion Criteria: * a) Subject with significant coronary artery stenosis on coronary angiography (diameter stenosis ≥90% or 50-90% with fractional flow reserve \[FFR\] ≤0.80) b) Subject scheduled for cardiac replacement therapy (heart transplantation or left ventricular assisted device \[LVAD\] implantation) c) HF due to restrictive cardiomyopathy, active myocarditis, or constrictive pericarditis d) Significant valvular heart disease requiring surgery e) Subject who have non-cardiac co-morbid conditions with life expectancy \<1 year
Where it's running
-
Samsung Medical Center
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Ki Hong Choi, MD — Samsung Medical Center
- Study coordinator: Ki Hong Choi, MD
- Email: cardiokh@gmail.com
- Phone: 82-2-3410-3419
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.