Cardiomyopathy, DilatedRECORDNCT02445534
Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
An observational study of Cardiomyopathy, Dilated, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiomyopathy, Dilated
- What is being tested?
- Autologous stem cell therapy
- How many people
- 250 participants
- Where
- 1 siteSlovenia
- Study dates
- Jan 2005to May 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
UMC Ljubljana
Ljubljana, 1000
Bojan Vrtovec, MD, PhD, +3861 522 1157, bojan.vrtovec@gmail.com
Gregor Poglajen, MD, PhD, +3861 522 1148, gregor.poglajen@gmail.com
About this study
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.
Read the 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.
- Conditions
- Cardiomyopathy, Dilated
- Being tested
- Autologous stem cell therapy
- Keywords
- Cell Therapy
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous stem cell therapyBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplantation-free survival
Survival after 5 years without undergoing heart transplantation
Measured: 5 years
Secondary outcomes (4)
Changes in left ventricular ejection fraction
Measured: 5 years
Changes in left ventricular dimensions
Measured: 5 years
Changes in left ventricular diastolic function
Measured: 5 years
Changes in right ventricular function
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJan 2005
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiomyopathy, DilatedStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojan Vrtovec, University Medical Centre Ljubljana
- Investigators
- Bojan Vrtovec, MD, PhD, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445534
- Sponsor's protocol ID
- RECORD
- Acronym
- RECORD
- Status last verified
- Jul 2024
- First submitted
- 12 May 2015
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Frljak S, Poglajen G, Zemljic G, Cerar A, Haddad F, Terzic A, Vrtovec B. Larger End-Diastolic Volume Associates With Response to Cell Therapy in Patients With Nonischemic Dilated Cardiomyopathy. Mayo Clin Proc. 2020 Oct;95(10):2125-2133. doi: 10.1016/j.mayocp.2020.02.031.
PubMed 33012343Bervar M, Kozelj M, Poglajen G, Sever M, Zemljic G, Frljak S, Cukjati M, Cernelc P, Haddad F, Vrtovec B. Effects of Transendocardial CD34+ Cell Transplantation on Diastolic Parameters in Patients with Nonischemic Dilated Cardiomyopathy. Stem Cells Transl Med. 2017 Jun;6(6):1515-1521. doi: 10.1002/sctm.16-0331. Epub 2017 Mar 11.
PubMed 28296283
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02445534
- Acronym / sponsor ID
- RECORD / RECORD
- Conditions
- Cardiomyopathy, Dilated
- Keywords
- Cell Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous stem cell therapyAll 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. | Biological | – |
Primary outcome
Transplantation-free survival
Time frame: 5 years
Survival after 5 years without undergoing heart transplantation
4 secondary outcomes
Changes in left ventricular ejection fraction
Time frame: 5 years
Changes in left ventricular dimensions
Time frame: 5 years
Changes in left ventricular diastolic function
Time frame: 5 years
Changes in right ventricular function
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 33012343Frljak S, Poglajen G, Zemljic G, Cerar A, Haddad F, Terzic A, Vrtovec B. Larger End-Diastolic Volume Associates With Response to Cell Therapy in Patients With Nonischemic Dilated Cardiomyopathy. Mayo Clin Proc. 2020 Oct;95(10):2125-2133. doi: 10.1016/j.mayocp.2020.02.031.
- Derived from this study: PubMed 28296283Bervar M, Kozelj M, Poglajen G, Sever M, Zemljic G, Frljak S, Cukjati M, Cernelc P, Haddad F, Vrtovec B. Effects of Transendocardial CD34+ Cell Transplantation on Diastolic Parameters in Patients with Nonischemic Dilated Cardiomyopathy. Stem Cells Transl Med. 2017 Jun;6(6):1515-1521. doi: 10.1002/sctm.16-0331. Epub 2017 Mar 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bojan Vrtovec, MD, PhD principal investigator
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, Dilated, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bojan Vrtovec, MD, PhD (+3861 522 1157, bojan.vrtovec@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplantation-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02445534, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.