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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Despite advances in medical technology, heart failure remains a major cause of illness on a
global scale. Medical research, over recent years, has shown that adult stem cells (as
opposed to embryonic stem cells) are present in most organs of adult humans. Their exact
function is however poorly understood. An improved understanding of what these stem cells do
and how they work is essential if effective stem cell treatments are to be developed in
future.

The project seeks to examine the levels of a number of different types of stem cells in
patients with heart failure, compared to healthy volunteers. The project also aims to measure
stem cell levels in patients with heart failure at the time of a sudden worsening in their
condition and then later in the same patients following recovery.

The project entails the taking of blood samples in order to measure the stem cell levels in
the blood. The study does NOT involve any form of treatment with stem cells. Two groups of
patients will be studied; patients with heart failure and healthy volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01027403
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01027403