Cardiomyopathy, Dilated
Conditions
Keywords
Cell Therapy
Brief summary
Although several studies have demonstrated beneficial effects of stem cell therapy in patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of response to therapy remain undefined. The aim of this registry is to pool long-term clinical data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy in an attempt to better define predictors of response to such treatment.
Detailed description
Registry will include all patients who underwent intracoronary or intramyocardial cell therapy as a part of clinical trials performed at UMC Ljubljana from January 2005 until January 2018. Patients will be followed on regular basis in a dedicated heart failure outpatient clinic, clinical data will be collected and stored in a secure central database. Data will be analyzed in periodic intervals by an independent Data monitoring board in an attempt to better define the predictors of clinical response to cell therapy in this patient population.
Interventions
BIOLOGICALAutologous stem cell therapy
All patients received granulocyte-colony stimulating factor (G-CSF; 5 mg/kg, 5 days). CD34+ cell were then collected by apheresis and injected transendocardially or intracororonary.
Sponsors
University Medical Centre Ljubljana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient inclusion criteria consisted of the following: age 18-65 years old, diagnosis of DCM according to the European Society of Cardiology position statement (9), optimal medical management for at least 6 months, left ventricular ejection fraction (LVEF) \<40%, and New York Heart Association functional Class III on stable medical therapy for at least 3 months before referral.
Exclusion criteria
* Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transplantation-free survival | 5 years | Survival after 5 years without undergoing heart transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Changes in left ventricular ejection fraction | 5 years |
| Changes in left ventricular dimensions | 5 years |
| Changes in left ventricular diastolic function | 5 years |
| Changes in right ventricular function | 5 years |
Other
| Measure | Time frame |
|---|---|
| Changes in exercise capacity | 5 years |
| Changes in NT-proBNP | 5 years |
Countries
Slovenia
Contacts
Primary ContactBojan Vrtovec, MD, PhD
Backup ContactGregor Poglajen, MD, PhD
Outcome results
None listed