Evaluating coronary microvascular dysfunction in heart failure patients without significant coronary artery disease
Distribution and Clinical Implication of Coronary Flow Reserve and Index of Microcirculatory Resistance in Patients With Heart Failure With Preserved Ejection Fraction Without Significant Coronary Artery Disease
This study is trying to see how common small blood vessel problems are in heart failure patients who don't have major artery blockages, to help improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04788576 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of coronary microvascular dysfunction (CMD) in patients diagnosed with heart failure with preserved ejection fraction (HFpEF) who do not have significant coronary artery disease. It utilizes the HFA-PEFF scoring system to identify eligible patients and employs both non-invasive and invasive methods to evaluate coronary flow reserve and microcirculatory resistance. The study seeks to understand the prognostic implications of CMD in this patient population, which may contribute to better management strategies for HFpEF. By exploring the relationship between CMD and HFpEF, the study hopes to shed light on underlying pathophysiological mechanisms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with HFpEF and dyspnea on exertion who require coronary angiography.
Not a fit: Patients with reduced ejection fraction or significant coronary artery stenosis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with heart failure with preserved ejection fraction.
How similar studies have performed: While there have been studies on CMD and HFpEF, this specific approach using invasive physiologic indices is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject must be at least 19 years of age. * Subject with preserved ejection fraction (ejection fraction \> 50%) * Subject presented with dyspnea on exertion (NYHA Grade 2 or more) and diagnosed as HFpEF using HFA-PEFF scoring system (HFA-PEFF ≥5 or 2-4 with abnormal stress test or invasive hemodynamic test) * Subject who clinically need coronary angiography * Subject who is able to voluntarily sign informed consent form Exclusion Criteria: * Subject with reduced ejection fraction (\<50%) * Subject with significant coronary artery stenosis on coronary angiography (diameter stenosis ≥90% or 50-90% with fractional flow reserve \[FFR\] ≤0.80) * Subject who has other obvious causes of dyspnea (ex, lung disease) * Subject who have non-cardiac co-morbid conditions with life expectancy \<1 year
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Ki Hong Choi, MD — Samsung Medical Center
- Study coordinator: Ki Hong Choi, MD
- Email: cardiokh@gmail.com
- Phone: 82-2-3410-1246
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.