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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01027403




Registration number
NCT01027403
Ethics application status
Date submitted
4/12/2009
Date registered
8/12/2009
Date last updated
4/06/2015

Titles & IDs
Public title
Evaluation of Circulating Levels of Adult Stem Cells in the Peripheral Blood of Patients With Acute Decompensated Heart Failure and Following Stabilization, in Comparison With Healthy Volunteers
Scientific title
Evaluation of Circulating Levels of Adult Stem Cells in the Peripheral Blood of Patients With Acute Decompensated Heart Failure and Following Stabilization, in Comparison With Healthy Volunteers
Secondary ID [1] 0 0
234/07
Universal Trial Number (UTN)
Trial acronym
CIRCSTEM-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Healthy volunteers -

Acute decompensated heart failure -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in circulating levels of adult stem cells in the peripheral blood of patients with acute decompensated heart failure and following stabilization, in comparison with healthy volunteers.
Timepoint [1] 0 0
Baseline and following stablization of heart failure

Eligibility
Key inclusion criteria
* Men or women 18 years or older
* Hospitalized for the management of ADHF or diagnosed with ADHF within 48 hours after being hospitalized for another reason (patients/cases ONLY)
* Signed (by the subjects or their legally acceptable representatives) informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Hospitalized for > 48 hours before study enrollment
* Likely to be discharged from the hospital in 24 hours or less
* Current haematological disorder or haematological malignancy
* Active infection / sepsis
* Major organ insufficiency (other than heart failure in heart failure patients)
* Pregnancy
* Healthy volunteers found to have signs and/or symptoms of heart failure on screening.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MBBS FRACP PhD
Address 0 0
Monash University / Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01027403