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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University Medical Centre Groningen.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01086787
First received: March 12, 2010
Last updated: June 10, 2010
Last verified: March 2010

March 12, 2010
June 10, 2010
August 2010
August 2011   (final data collection date for primary outcome measure)
Paracrine properties of bone marrow cells from patients with heart failure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01086787 on ClinicalTrials.gov Archive Site
  • To study preconditioning of different bone marrow stem cells with different cytokines [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate potential molecular mechanisms involved [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • To find mechanisms to enhance expansion of different bone marrow stem cells in vitro [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure
Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, serum, white cells, urine, bone marrow

Non-Probability Sample

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.

Heart Failure
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery
  • Non heart failure patients
    Patients without heart failure undergoing open chest surgery
    Intervention: Other: Surgery
  • Orthopedic patients
    Patients without heart failure undergoing orthopedic surgery
    Intervention: Other: Surgery
  • Heart failure patients
    Patients with heart failure undergoing open chest surgery.
    Intervention: Other: Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
125
December 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
Italy,   Netherlands
 
NCT01086787
WTR-ECG-5
No
R.A. de Boer, MD, PhD, University Medical Center Groningen
University Medical Centre Groningen
Not Provided
Principal Investigator: W. T. Ruifrok, MD University Medical Centre Groningen
Study Director: R. A. de Boer, MD, PhD University Medical Centre Groningen
Study Chair: W. H. van Gilst, PhD University Medical Centre Groningen
Study Director: M. Gnecchi, MD, PhD University of Pavia
Principal Investigator: L. Kleijn, MD University Medical Centre Groningen
University Medical Centre Groningen
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP