Clinical trial NCT02445534: Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
Official title: Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiomyopathy, Dilated
Keywords: Cell Therapy
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients enrolled in clinical trials of stem cell therapy in non-ischemic dilated cardiomyopathy at UMC Ljubljana from January, 2005 will be enrolled.

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.

Eligibility 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.

Primary outcomes:
measure: Transplantation-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Changes in left ventricular ejection fraction
timeFrame: 5 years
measure: Changes in left ventricular dimensions
timeFrame: 5 years
measure: Changes in left ventricular diastolic function
timeFrame: 5 years
measure: Changes in right ventricular function
timeFrame: 5 years
Other outcomes:
measure: Changes in exercise capacity
timeFrame: 5 years
measure: Changes in NT-proBNP
timeFrame: 5 years
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
affiliation: UMC Ljubljana
name: Bojan Vrtovec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frljak S, Poglajen G, Zemljic G, Cerar A, Haddad F, Terzic A, Vrtovec B. Larger End-Diastolic Volume Associates With Response to Cell Therapy in Patients With Nonischemic Dilated Cardiomyopathy. Mayo Clin Proc. 2020 Oct;95(10):2125-2133. doi: 10.1016/j.mayocp.2020.02.031.
citation: Bervar M, Kozelj M, Poglajen G, Sever M, Zemljic G, Frljak S, Cukjati M, Cernelc P, Haddad F, Vrtovec B. Effects of Transendocardial CD34+ Cell Transplantation on Diastolic Parameters in Patients with Nonischemic Dilated Cardiomyopathy. Stem Cells Transl Med. 2017 Jun;6(6):1515-1521. doi: 10.1002/sctm.16-0331. Epub 2017 Mar 11.