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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06243653
Other study ID # HFrEF-CMD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 9, 2023
Est. completion date December 31, 2027

Study information

Verified date February 2024
Source Samsung Medical Center
Contact Ki Hong Choi, MD
Phone 82-2-3410-3419
Email cardiokh@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aims to evaluate the incidence of coronary microvascular dysfunction (CMD) and its prognostic implication for the improvement of left ventricular function in patients who have been diagnosed with heart failure with reduced ejection fraction (HFrEF) caused by non-ischemic etiology.


Description:

HF is a clinical syndrome characterized by dyspnea or exertional limitation due to impairment of ventricular filling or ejection of blood or both. HFrEF occurs when the left ventricular ejection fraction (LVEF) is 40% or less and is accompanied by progressive left ventricular dilatation and adverse cardiac remodeling. Among them, a substantial portion of patients had non-ischemic etiology.4 The CMD, defined by impaired coronary flow reserve (CFR), is commonly observed in patients with cardiomyopathies caused by non-ischemic etiology and is well-known to be associated with poor prognosis independently of the degree of left ventricular functional abnormality. However, the presence of CMD can be more specifically evaluated by invasive physiologic assessment using both CFR and the index of microcirculatory resistance (IMR) than by non-invasive methods (doppler echocardiography, positron emission tomography, or cardiac magnetic resonance imaging [MRI]) measuring CFR alone. Considering that CMD, defined by depressed CFR with elevated IMR, reflects the impaired myocardial flow and microvascular damages, there was a possibility that it may be a predictor of irreversible myocardial damages in HFrEF patients with non-ischemic etiology. Nevertheless, there has been limited data regarding the association between the improvement of LV function and CMD for patients with HFrEF caused by non-ischemic etiology after guideline-directed medical treatment (GDMT). Therefore, the investigators sought to evaluate the incidence of CMD and its prognostic implication for the improvement of left ventricular function after GDMT in patients who have been diagnosed with HFrEF caused by non-ischemic etiology.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
CMD test
Measured CFR and IMR

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of HFiEF* at 12 months HFiEF was defined as LVEF >40% measured by echocardiography at 12 months.1 1-year follow-up
Secondary Correlation between CMD and left ventricular end diastolic pressure 1 year
Secondary Correlation between CMD and delta LVEF from baseline to 12 months 1 year
Secondary Correlation between CMD and E/e' 1 year
Secondary Correlation between CMD and delta LV systolic dimension from baseline to 12 months 1 year
Secondary Correlation between CMD and delta LV diastolic dimension from baseline to 12 months 1-year follow-up
Secondary Correlation between CMD and late gadolinium enhancement measured by cardiac MRI 1 year
Secondary Correlation between CMD and pulmonary artery wedge pressure 1 year
Secondary Correlation between CMD and mean pulmonary artery pressure 1 year
Secondary Correlation between CMD and pulmonary artery pulsatility index (PAPi) 1 year
Secondary Correlation between CMD and cardiac output/cardiac index 1 year
Secondary Correlation between CMD and delta NT-proBNP from baseline to 12 months follow-up 1-year follow-up
Secondary Proportion of CMD according to etiology 1 year
Secondary Rates of All-cause death 1-year follow-up
Secondary Rates of Cardiac death 1-year follow-up
Secondary Rates of Readmission due to HF 1-year follow-up
Secondary Rates of Readmission 1-year follow-up
Secondary Rates of Implantation of implantable cardioverter defibrillator 1-year follow-up
Secondary Rates of Cardiac replacement therapy (heart transplantation or LVAD) 1-year follow-up
Secondary Changes of quality of life for HF (Kansas City Cardiomyopathy Questionnaire [KCCQ]) 1-year follow-up
Secondary Total medical cost 1-year follow-up
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