Status:
RECRUITING
Distribution and Clinical Implication of CMD in Patients With HFpEF Without Significant CAD
Lead Sponsor:
Samsung Medical Center
Conditions:
Heart Failure With Preserved Ejection Fraction
Coronary Microvascular Dysfunction
Eligibility:
All Genders
19+ years
Brief Summary
To evaluate the incidence of coronary microvascular dysfunction (CMD) and its' prognostic implication in patients who have diagnosed as heart failure with preserved ejection fraction (HFpEF) confirmed...
Detailed Description
Heart failure with preserved ejection fraction (HFpEF) is a clinical syndrome in patients with current or prior symptoms of HF with a left ventricular ejection fraction (LVEF) ≥ 50 percent and evidenc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04788576
Start Date
January 25 2021
End Date
December 31 2024
Last Update
January 30 2024
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351