Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

Recruiting

• Conditions: Cardiomyopathy, Dilated

• Registration Number: NCT02445534
• Lead Sponsor: University Medical Centre Ljubljana

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2027-01
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transplantation-free survival	5 years	Survival after 5 years without undergoing heart transplantation

Secondary Outcome Measures

Name	Time	Method
Changes in left ventricular diastolic function	5 years
Changes in left ventricular ejection fraction	5 years
Changes in left ventricular dimensions	5 years
Changes in right ventricular function	5 years

Trial Locations

Locations (1)

UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia