Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02445534

Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cardiomyopathy, Dilated Cardiomegaly Cardiomyopathies Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous stem cell therapy

Biological

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.

Primary outcomes

  1. Transplantation-free survival

    Time frame: 5 years

    Survival after 5 years without undergoing heart transplantation

Secondary outcomes

  1. Changes in left ventricular ejection fraction

    Time frame: 5 years

  2. Changes in left ventricular dimensions

    Time frame: 5 years

  3. Changes in left ventricular diastolic function

    Time frame: 5 years

  4. Changes in right ventricular function

    Time frame: 5 years

Other outcomes

  1. Changes in exercise capacity

    Time frame: 5 years

  2. Changes in NT-proBNP

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Bojan Vrtovec, MD, PhD

CONTACT

[email protected]

+3861 522 1157

Gregor Poglajen, MD, PhD

CONTACT

[email protected]

+3861 522 1148

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Acronym: RECORD

Important dates

Study start
2005
Primary completion
2027
Study completion
2027
First posted
May 15, 2015
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.