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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with heart failure with reduced ejection fraction (HFrEF) without significant coronary artery disease (non-ischemic cardiomyopathy)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CMD test

    Diagnostic test

    Measured CFR and IMR

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: HFrEF1 intervention

Trial outcomes

Primary outcomes

1

Proportion of HFiEF* at 12 months

HFiEF was defined as LVEF \>40% measured by echocardiography at 12 months.1

Time frame
1-year follow-up

Secondary outcomes

1

Correlation between CMD and left ventricular end diastolic pressure

Time frame
1 year
2

Correlation between CMD and delta LVEF from baseline to 12 months

Time frame
1 year
3

Correlation between CMD and E/e'

Time frame
1 year
4

Correlation between CMD and delta LV systolic dimension from baseline to 12 months

Time frame
1 year

Other outcomes

Sponsors and contacts

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