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

Heart Failure Clinical Trial

— HFrEF-CMD  

Official title:

The Role of Coronary Microvascular Dysfunction in Improving Left Ventricular Systolic Function Using Registry for Evaluation of Factors associatEd With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology (REFERENCE).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243653
• Other study ID #: HFrEF-CMD
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Microvascular Angina
• Non-ischemic Cardiomyopathy

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