Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy (RECORD)

U

University Medical Centre Ljubljana

Status

Enrolling

Conditions

Cardiomyopathy, Dilated

Treatments

Biological: Autologous stem cell therapy

Study type

Observational

Funder types

Other

Identifiers

NCT02445534
RECORD

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

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Central trial contact

Bojan Vrtovec, MD, PhD; Gregor Poglajen, MD, PhD

Data sourced from clinicaltrials.gov

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