Actively Recruiting
The Role of Coronary Microvascular Dysfunction in Improving Left Ventricular Function Using Registry for Evaluation of Factors in Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology
Led by Samsung Medical Center · Updated on 2024-02-06
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the relationship between coronary microvascular dysfunction (CMD) and the improvement of left ventricular systolic function in patients diagnosed with heart failure with reduced ejection fraction (HFrEF) caused by non-ischemic causes. This condition involves the heart's reduced ability to pump blood effectively and is characterized by symptoms like breathlessness and exercise limitation. The study focuses on patients with an ejection fraction of 40% or less and explores how CMD, measured invasively, may predict heart muscle damage and affect recovery after standard medical treatment. The study involves patients with HFrEF without significant coronary artery disease who undergo diagnostic testing to assess CMD using coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR). These invasive assessments provide detailed information on coronary microvascular health. Participants receive guideline-directed medical treatment (GDMT) for heart failure, and the study evaluates how CMD relates to changes in heart function over time. Participants are followed for 12 months, during which researchers measure improvements in heart function and collect data through clinical assessments, imaging such as cardiac MRI, and hemodynamic measurements. Outcomes include the proportion of patients showing heart function improvement, correlations between CMD and various heart pressures, volumes, and biomarkers, as well as rates of hospitalization, death, and quality of life changes. The study aims to understand CMD's prognostic significance in non-ischemic HFrEF over a one-year period.
CONDITIONS
Brief Title
Relationship Between Coronary Microvascular Dysfunction and Improvement of Left Ventricular Systolic Function in Patients With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 19 years old
- Symptoms or signs of heart failure with NYHA class 2 or higher breathlessness
- Left ventricular ejection fraction of 40% or less
- Clinically need coronary angiography
- Able to voluntarily sign informed consent
You will not qualify if you...
- Significant coronary artery stenosis (≥90% diameter or 50-90% with fractional flow reserve ≤0.80)
- Scheduled for cardiac replacement therapy such as heart transplantation or left ventricular assist device implantation
- Heart failure due to restrictive cardiomyopathy, active myocarditis, or constrictive pericarditis
- Significant valvular heart disease requiring surgery
- Non-cardiac conditions with life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo tests to measure coronary microvascular dysfunction including coronary flow reserve (CFR) and index of microcirculatory resistance (IMR).
1 visit (in-person)
Duration - 12 months
Participants are observed for changes in left ventricular function and clinical outcomes over the course of 12 months following guideline-directed medical treatment.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
K
Ki Hong Choi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here