Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

Cardiomyopathy, Dilated Clinical Trial

— RECORD  

Official title:

Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02445534
• Other study ID #: RECORD
• Status: Recruiting
• Start date: January 2005
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: University Medical Centre Ljubljana
• Contact: Bojan Vrtovec, MD, PhD
• Phone: +3861 522 1157
• Email: bojan.vrtovec[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated

Intervention

Biological:
• Autologous 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.

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in exercise capacity		5 years
Other	Changes in NT-proBNP		5 years
Primary	Transplantation-free survival	Survival after 5 years without undergoing heart transplantation	5 years
Secondary	Changes in left ventricular ejection fraction		5 years
Secondary	Changes in left ventricular dimensions		5 years
Secondary	Changes in left ventricular diastolic function		5 years
Secondary	Changes in right ventricular function		5 years