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Trial record 78 of 157 for:    Idiopathic Dilated Cardiomyopathy

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

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ClinicalTrials.gov Identifier: NCT02445534
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bojan Vrtovec, 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.

Condition or disease Intervention/treatment
Cardiomyopathy, Dilated Biological: Autologous stem cell therapy

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
Study Start Date : January 2005
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Transplantation-free survival [ Time Frame: 5 years ]
    Survival after 5 years without undergoing heart transplantation


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Changes in exercise capacity [ Time Frame: 5 years ]
  2. Changes in NT-proBNP [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445534


Contacts
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Contact: Bojan Vrtovec, MD, PhD +3861 522 1157 bojan.vrtovec@gmail.com
Contact: Gregor Poglajen, MD, PhD +3861 522 1148 gregor.poglajen@gmail.com

Locations
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Slovenia
UMC Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Bojan Vrtovec, MD, PhD    +3861 522 1157    bojan.vrtovec@gmail.com   
Contact: Gregor Poglajen, MD, PhD    +3861 522 1148    gregor.poglajen@gmail.com   
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Bojan Vrtovec, MD, PhD UMC Ljubljana

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bojan Vrtovec, Medical Director, Advanced Heart Failure and Transplantation Center, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02445534     History of Changes
Other Study ID Numbers: RECORD
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Keywords provided by Bojan Vrtovec, University Medical Centre Ljubljana:
Cell Therapy
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly