None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : All study participants will receive granulocyte colony-stimulating factor (G-CSF) at a standard dose of 10 mcg/kg/day administered subcutaneously once daily for 5
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older at the time of written informed consent. 2. Patients with dilated cardiomyopathy who have NYHA Functional Class II-IV dyspnea despite receiving optimal therapy* for at least 6 months, and with left ventricular ejection fraction <45% confirmed by echocardiography. *Optimal therapy includes guideline-directed medical therapy and device therapy such as cardiac resynchronization therapy. 3. Patients in whom coronary artery disease has been excluded, defined as < 50% coronary artery stenosis on coronary angiography or non-invasive coronary computed tomography angiography. 4. Patients at risk of ventricular arrhythmia (defined as Left ventricular ejection fraction = 35% with NYHA Class II–III symptoms despite at least 3 months of optimal medical therapy) may undergo implantable cardioverter-defibrillator implantation for primary prevention of sudden cardiac death prior to study enrollment, in accordance with current guidelines (Class IIa, 2022 Korean Society of Heart Failure guidelines). 5. Patients who are capable of complying with the study protocol. 6. Patients who have voluntarily provided written informed consent to participate in this study (by the patient or a legally authorized representative).
Exclusion criteria
Exclusion criteria: 1. NYHA Functional Class I. 2. Left ventricular ejection fraction = 45% on echocardiography or other cardiac imaging prior to study enrollment. 3. Cardiogenic shock. 4. Acute heart failure with signs and symptoms such as pulmonary edema or new-onset peripheral edema. 5. Severe left ventricular dysfunction (left ventricular ejection fraction 140 kg. 21. Women of childbearing potential who are beta-human chorionic gonadotropin positive or unwilling to use appropriate contraception during the study. Acceptable methods include hormonal contraception, intrauterine device/system, double barrier methods (male condom plus diaphragm or cervical cap), or surgical sterilization (vasectomy, bilateral tubal ligation). 22. Positive screening test for infectious diseases, including Human Immunodeficiency virus, hepatitis B virus, hepatitis C virus , human T-lymphotropic virus , cytomegalovirus, or syphilis. 23. Any condition that, in the investigator’s judgment, makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in left ventricular ejection fraction(LVEF) measured by cardiac magnetic resonance imaging (MRI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cardiac biomarkers (change in NT-proBNP levels);Changes in exercise capacity (cardiopulmonary exercise testing and 6-minute walk test);Changes in left ventricular ejection fraction and ventricular size measured by cardiac magnetic resonance imaging;Assessment of myocardial blood flow, myocardial flow reserve, and coronary flow reserve measured by positron emission tomography;Changes in NYHA functional class and quality of life;Assessment of procedural safety (changes in cardiac enzymes);Incidence of major adverse cardiac events;Mortality (All-Cause Death, Cardiac Death);Procedure-related complications(G-CSF injection-related, bone marrow aspiration-related, intracoronary infusion-related);Serious or life-threatening arrhythmias;Study procedure-related adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactJiMoon Hwang
Chonnam National University Hospital
Outcome results
None listed