RECORD: Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Transplantation-free survival [5 years]
Survival after 5 years without undergoing heart transplantation
Secondary Outcome Measures
- 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 Outcome Measures
- Changes in exercise capacity [5 years]
- Changes in NT-proBNP [5 years]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UMC Ljubljana | Ljubljana | Slovenia | 1000 |
Sponsors and Collaborators
- University Medical Centre Ljubljana
Investigators
- Principal Investigator: Bojan Vrtovec, MD, PhD, UMC Ljubljana
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECORD