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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 May 2023 |
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Main ID: |
NCT02445534 |
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Date of registration:
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12/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
RECORD |
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Scientific title:
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Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02445534 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Bojan Vrtovec, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UMC Ljubljana |
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Name:
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Bojan Vrtovec, MD, PhD |
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Address:
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Telephone:
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+3861 522 1157 |
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Email:
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bojan.vrtovec@gmail.com |
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Affiliation:
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Name:
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Bojan Vrtovec, MD, PhD |
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Address:
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Telephone:
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+3861 522 1157 |
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Email:
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bojan.vrtovec@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiomyopathy, Dilated
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Intervention(s)
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Biological: Autologous stem cell therapy
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Primary Outcome(s)
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Transplantation-free survival
[Time Frame: 5 years]
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Secondary Outcome(s)
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Changes in left ventricular dimensions
[Time Frame: 5 years]
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Changes in left ventricular ejection fraction
[Time Frame: 5 years]
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Changes in right ventricular function
[Time Frame: 5 years]
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Changes in left ventricular diastolic function
[Time Frame: 5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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