Evaluating coronary microvascular dysfunction in heart failure patients
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).
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06243653 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there is limited data on this specific relationship, similar studies have explored CMD in heart failure, indicating potential for meaningful insights.
Eligibility criteria
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 this trial is running
Seoul
- 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
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.