Heart FailureBM-CHFNCT01086787
Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure
An observational study of Heart Failure, run by University Medical Center Groningen at 2 sites in 2 countries.
Trial summary
The investigators hypothesize that chronic heart failure is associated with a general stem cell dysfunction, which translates into reduced paracrine function of adult stem cells from patients with chronic heart failure as compared to patients with preserved systolic function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Surgery
- How many people
- 125 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2010to Dec 2011
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Man and woman, undergoing cardiothoracic surgery, older than 18 years of age, with and without preserved left ventricular ejection fraction (LVEF <40% and >40%). Controls are man and women, older than 18 years of age, scheduled for orthopaedic surgery without a history of cardiac disease.
Who may be able to join
- For all participants:
- Before any study-specific procedures, the appropriate written informed consent must be obtained.
- Male and female older than 18 years of age.
- For the cardiac patients:
- Being accepted for cardiothoracic surgery with the use of open chest surgery
- A known left ventricular ejection fraction, either assessed by echocardiography, MUGA or MRI. If LVEF <40% a subject will be assigned to the chronic heart failure group, if LVEF >40% a subject will be assigned to the control group.
- For the non-cardiac patients:
- Accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery.
Who cannot join
- An unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g. at risk of complications or adverse events unrelated to study participation).
- Younger than 18 years of age.
- Clinical history of chronic kidney disease (at any point prior to registration).
- Any known hepatic disease.
- Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
- Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period.
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- Participation in any investigational device or drug trial(s) or receiving investigational agent(s) within 30 days.
- Any condition (e.g. psychiatric illness, etc.) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Legally incompetent adults, for which reason what so ever.
- For the non-cardiac patients:
- A known history of cardiovascular disease.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Department of Heart, Blood and Lung , University of Pavia
Pavia
M. Gnecchi, MD, PhD, massimiliano.gnecchi@unipv.it
M. Gnecchi, MD, PhD
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9700 RB
R. A. de Boer, MD, PhD, +31 50 631 61 61 ext. 15381, r.a.de.boer@thorax.umcg.nl
W. T. Ruifrok, MD, +31 50 631 61 61 ext. 10248, w.t.ruifrok@thorax.umcg.nl
About this study
The investigators hypothesize that chronic heart failure is associated with a general stem cell dysfunction, which translates into reduced paracrine function of adult stem cells from patients with chronic heart failure as compared to patients with preserved systolic function.
- Conditions
- Heart Failure
- Being tested
- Surgery
- Keywords
- Heart failure, Bone marrow, Bone marrow mononuclear cells, Surgery, Orthopedic surgery, Cardiac surgery
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Patients undergoing surgery for either cardiac surgery or orthopedic surgery
| Study group | Role | What they receive |
|---|---|---|
| Non heart failure patients | Patients without heart failure undergoing open chest surgery Receives: Other: Surgery | |
| Orthopedic patients | Patients without heart failure undergoing orthopedic surgery Receives: Other: Surgery | |
| Heart failure patients | Patients with heart failure undergoing open chest surgery. Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paracrine properties of bone marrow cells from patients with heart failure
To compare the paracrine properties of bone marrow-derived stem cells harvested from patients suffering chronic heart failure vs healthy subjects. In particular, we aim to determine if the cytoprotective, pro-angiogenic and anti-fibrotic effects mediated by bone marrow stem cells of heart failure patients are similar to those from healthy patients.
Measured: 1 day
Secondary outcomes (4)
To study preconditioning of different bone marrow stem cells with different cytokines
Measured: 1 day
To study in detail the temporal and spatial expression of paracrine factors in bone marrow stem cells in vitro, and to study the differences between bone marrow stem cells from patients with and without chronic heart failure
Measured: 1 day
To evaluate potential molecular mechanisms involved
Measured: 1 day
To find mechanisms to enhance expansion of different bone marrow stem cells in vitro
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionDec 2011 (estimated)
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.
- More trials run by University Medical Center GroningenThe 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- W. T. Ruifrok, MD, Principal investigator, University Medical Center GroningenR. A. de Boer, MD, PhD, Study director, University Medical Center GroningenW. H. van Gilst, PhD, Study chair, University Medical Center GroningenM. Gnecchi, MD, PhD, Study director, University of PaviaL. Kleijn, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086787
- Sponsor's protocol ID
- WTR-ECG-5
- Acronym
- BM-CHF
- Status last verified
- Mar 2010
- First submitted
- 12 Mar 2010
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01086787
- Acronym / sponsor ID
- BM-CHF / WTR-ECG-5
- Conditions
- Heart Failure
- Keywords
- Heart failure, Bone marrow, Bone marrow mononuclear cells, Surgery, Orthopedic surgery, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Mar 2010 (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.
The investigators hypothesize that chronic heart failure is associated with a general stem cell dysfunction, which translates into reduced paracrine function of adult stem cells from patients with chronic heart failure as compared to patients with preserved systolic function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non heart failure patients | – | Other: SurgeryPatients without heart failure undergoing open chest surgery |
| Orthopedic patients | – | Other: SurgeryPatients without heart failure undergoing orthopedic surgery |
| Heart failure patients | – | Other: SurgeryPatients with heart failure undergoing open chest surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Man and woman, undergoing cardiothoracic surgery, older than 18 years of age, with and without preserved left ventricular ejection fraction (LVEF <40% and >40%). Controls are man and women, older than 18 years of age, scheduled for orthopaedic surgery without a history of cardiac disease.
Key inclusion criteria (8 listed)
- Before any study-specific procedures, the appropriate written informed consent must be obtained.
- Male and female older than 18 years of age.
- Being accepted for cardiothoracic surgery with the use of open chest surgery
- A known left ventricular ejection fraction, either assessed by echocardiography, MUGA or MRI. If LVEF <40% a subject will be assigned to the chronic heart failure group, if LVEF >40% a subject will be assigned to the control group.
- Accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery.
Key exclusion criteria (11 listed)
- An unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g. at risk of complications or adverse events unrelated to study participation).
- Younger than 18 years of age.
- Clinical history of chronic kidney disease (at any point prior to registration).
- Any known hepatic disease.
- Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
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 |
|---|---|---|
| SurgeryPatients undergoing surgery for either cardiac surgery or orthopedic surgery | Other | Heart failure patients, Non heart failure patients, Orthopedic patients |
Primary outcome
Paracrine properties of bone marrow cells from patients with heart failure
Time frame: 1 day
To compare the paracrine properties of bone marrow-derived stem cells harvested from patients suffering chronic heart failure vs healthy subjects. In particular, we aim to determine if the cytoprotective, pro-angiogenic and anti-fibrotic effects mediated by bone marrow stem cells of heart failure patients are similar to those from healthy patients.
4 secondary outcomes
To study preconditioning of different bone marrow stem cells with different cytokines
Time frame: 1 day
To study in detail the temporal and spatial expression of paracrine factors in bone marrow stem cells in vitro, and to study the differences between bone marrow stem cells from patients with and without chronic heart failure
Time frame: 1 day
To evaluate potential molecular mechanisms involved
Time frame: 1 day
To find mechanisms to enhance expansion of different bone marrow stem cells in vitro
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
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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.
W. T. Ruifrok, MD principal investigator
University Medical Center Groningen
R. A. de Boer, MD, PhD study director
University Medical Center Groningen
W. H. van Gilst, PhD study chair
University Medical Center Groningen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University Medical Center Groningen at 2 sites in 2 countries.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact W. T. Ruifrok, MD (+31 50 361 61 61 ext. 10248, w.t.ruifrok@thorax.umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paracrine properties of bone marrow cells from patients with heart failure (time frame: 1 day). 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 11 Jun 2010.