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Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure (BM-CHF)

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ClinicalTrials.gov Identifier: NCT01086787
Recruitment Status : Unknown
Verified March 2010 by University Medical Center Groningen.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2010
Last Update Posted : June 11, 2010
Sponsor:
Information provided by:
University Medical Center Groningen

Brief 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.

Condition or disease Intervention/treatment
Heart Failure Other: Surgery

Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure
Study Start Date : August 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort Intervention/treatment
Non heart failure patients
Patients without heart failure undergoing open chest surgery
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery
Orthopedic patients
Patients without heart failure undergoing orthopedic surgery
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery
Heart failure patients
Patients with heart failure undergoing open chest surgery.
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. To study preconditioning of different bone marrow stem cells with different cytokines [ Time Frame: 1 day ]
  2. 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 ]
  3. To evaluate potential molecular mechanisms involved [ Time Frame: 1 day ]
  4. To find mechanisms to enhance expansion of different bone marrow stem cells in vitro [ Time Frame: 1 day ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum, white cells, urine, bone marrow


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

For all participants:

  1. Before any study-specific procedures, the appropriate written informed consent must be obtained.
  2. Male and female older than 18 years of age.

    For the cardiac patients:

  3. Being accepted for cardiothoracic surgery with the use of open chest surgery
  4. 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:

  5. Accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery.

Exclusion Criteria:

  1. 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).
  2. Younger than 18 years of age.
  3. Clinical history of chronic kidney disease (at any point prior to registration).
  4. Any known hepatic disease.
  5. Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
  6. Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period.
  7. Participation in any investigational device or drug trial(s) or receiving investigational agent(s) within 30 days.
  8. 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.
  9. Legally incompetent adults, for which reason what so ever.

    For the non-cardiac patients:

  10. A known history of cardiovascular disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086787


Contacts
Contact: W. T. Ruifrok, MD +31 50 361 61 61 ext 10248 w.t.ruifrok@thorax.umcg.nl
Contact: R. A. de Boer, MD, PhD +31 50 361 61 61 ext 15381 r.a.de.boer@thorax.umcg.nl

Locations
Italy
Department of Heart, Blood and Lung , University of Pavia Not yet recruiting
Pavia, Italy
Contact: M. Gnecchi, MD, PhD       massimiliano.gnecchi@unipv.it   
Principal Investigator: M. Gnecchi, MD, PhD         
Netherlands
University Medical Center Groningen Not yet recruiting
Groningen, Netherlands, 9700 RB
Contact: R. A. de Boer, MD, PhD    +31 50 631 61 61 ext 15381    r.a.de.boer@thorax.umcg.nl   
Contact: W. T. Ruifrok, MD    +31 50 631 61 61 ext 10248    w.t.ruifrok@thorax.umcg.nl   
Principal Investigator: W. T. Ruifrok, MD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: W. T. Ruifrok, MD University Medical Center Groningen
Study Director: R. A. de Boer, MD, PhD University Medical Center Groningen
Study Chair: W. H. van Gilst, PhD University Medical Center Groningen
Study Director: M. Gnecchi, MD, PhD University of Pavia
Principal Investigator: L. Kleijn, MD University Medical Center Groningen

Additional Information:
Responsible Party: R.A. de Boer, MD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01086787     History of Changes
Other Study ID Numbers: WTR-ECG-5
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: March 2010

Keywords provided by University Medical Center Groningen:
Heart failure
Bone marrow
Bone marrow mononuclear cells
Surgery
Orthopedic surgery
Cardiac surgery

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases