Heart FailureCIRCSTEM-HFNCT01027403
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
An observational study of Heart Failure, run by Monash University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute decompensated heart failure and healthy volunteers.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Despite advances in medical technology, heart failure remains a major cause of illness on a global scale. The quest for understanding this condition and developing new treatment strategies has led to the consideration of stem cells as a possible therapy. 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.
A number of stem cell research groups around the world have found that adult stem cells circulate in the blood of humans. These circulating cells are likely to have entered the bloodstream from the bone marrow and are thought to be traveling in the blood to get to other body organs where they may help repair damaged tissue. Interestingly, the levels of these circulating stem cells have been found to be different in healthy people compared to those with various diseases, including heart attacks and heart failure. This has lead researchers to think that these stem cells may play an important role in how the human body fights these diseases.
To date, levels of only one type of stem cell have been measured in patients with heart failure. Also, no one has studied 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. This information would be very valuable in expanding scientific knowledge of these stem cells and how they behave in the different stages of heart disease.
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. Following the obtainment of informed consent, a screening history, physical examination and routine blood tests will be performed. After this, a 50ml sample of blood will be taken from the study participant. This is equivalent to 10 teaspoonfuls of blood. The 50ml blood sample obtained will then be taken immediately to the laboratory for analysis.
In the case of patients with heart failure, in order to measure stem cell blood levels after recovery, one additional blood sample will be obtained; a 50ml blood sample just before the patient is sent home from hospital.
Patients with heart failure will be identified by health care staff at the Alfred Hospital. Healthy volunteers will be identified by use of a database of healthy volunteers who have expressed interest in participating in clinical studies. Potential study participants will be initially approached and provided with written information. If the potential participant wishes to proceed with the study, this involves one outpatient hospital visit for healthy volunteers. For patients with heart failure, the study involves two visits by study staff during the hospital admission.
- Conditions
- Heart Failure
- Keywords
- Heart failure, Adult stem cells, Circulating stem cells, Acute decompensated heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described | |
| Acute decompensated heart failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and following stablization of heart failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred
- Responsible party
- Principal investigator, Prof Henry Krum, Monash University
- Investigators
- Henry Krum, MBBS FRACP PhD, Principal investigator, Monash University / Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027403
- Sponsor's protocol ID
- 234/07
- Acronym
- CIRCSTEM-HF
- Status last verified
- Jun 2015
- First submitted
- 4 Dec 2009
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01027403
- Acronym / sponsor ID
- CIRCSTEM-HF / 234/07
- Conditions
- Heart Failure
- Keywords
- Heart failure, Adult stem cells, Circulating stem cells, Acute decompensated heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- The Alfred
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Dec 2009 (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.
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.
Detailed description
Despite advances in medical technology, heart failure remains a major cause of illness on a global scale. The quest for understanding this condition and developing new treatment strategies has led to the consideration of stem cells as a possible therapy. 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.
A number of stem cell research groups around the world have found that adult stem cells circulate in the blood of humans. These circulating cells are likely to have entered the bloodstream from the bone marrow and are thought to be traveling in the blood to get to other body organs where they may help repair damaged tissue. Interestingly, the levels of these circulating stem cells have been found to be different in healthy people compared to those with various diseases, including heart attacks and heart failure. This has lead researchers to think that these stem cells may play an important role in how the human body fights these diseases.
To date, levels of only one type of stem cell have been measured in patients with heart failure. Also, no one has studied 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. This information would be very valuable in expanding scientific knowledge of these stem cells and how they behave in the different stages of heart disease.
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. Following the obtainment of informed consent, a screening history, physical examination and routine blood tests will be performed. After this, a 50ml sample of blood will be taken from the study participant. This is equivalent to 10 teaspoonfuls of blood. The 50ml blood sample obtained will then be taken immediately to the laboratory for analysis.
In the case of patients with heart failure, in order to measure stem cell blood levels after recovery, one additional blood sample will be obtained; a 50ml blood sample just before the patient is sent home from hospital.
Patients with heart failure will be identified by health care staff at the Alfred Hospital. Healthy volunteers will be identified by use of a database of healthy volunteers who have expressed interest in participating in clinical studies. Potential study participants will be initially approached and provided with written information. If the potential participant wishes to proceed with the study, this involves one outpatient hospital visit for healthy volunteers. For patients with heart failure, the study involves two visits by study staff during the hospital admission.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
| Acute decompensated heart failure | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute decompensated heart failure and healthy volunteers.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Baseline and following stablization of heart failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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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. This study is not recruiting at the moment.
Henry Krum, MBBS FRACP PhD principal investigator
Monash University / Alfred Hospital
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 Heart Failure, run by Monash University at 1 site in Australia.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 4 Jun 2015. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline and following stablization of heart failure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2015.