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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02248532
Date of registration:	16/09/2014
Prospective Registration:	No
Primary sponsor:	University Medical Centre Ljubljana
Public title:	Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM) REMEDIUM
Scientific title:	Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy
Date of first enrolment:	January 2014
Target sample size:	66
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02248532
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 2/Phase 3

Countries of recruitment
Slovenia

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18-70 years old

- Diagnosis of DCM according to European Society of Cardiology position statement

- Left ventricular ejection fraction (LVEF) by echocardiography 20-40%,

- New York Heart Association (NYHA) functional class heart failure II or III for at
least 3 months before referral.

Exclusion Criteria:

- Acute multi-organ failure

- History of any malignant disease within 5 years

- Diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid
obesity)

- Pregnancy

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Dilated Cardiomyopathy

Intervention(s)

Biological: Stem cell therapy

Primary Outcome(s)

Change in left ventricular ejection fraction [Time Frame: baseline and 1 year]

Secondary Outcome(s)

Change in left ventricular dimension [Time Frame: 1 year]

Changes in regional wall motion [Time Frame: baseline and 1 year]

Change in exercise capacity [Time Frame: baseline and 1 year]

Change in NT-proBNP [Time Frame: baseline and 1 year]

Secondary ID(s)

REMEDIUM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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