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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

Tracking Information
First Submitted Date March 12, 2010
First Posted Date March 15, 2010
Last Update Posted Date June 11, 2010
Study Start Date August 2010
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2010)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 12, 2010)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure
Official Title Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum, white cells, urine, bone marrow
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.
Condition Heart Failure
Intervention Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 12, 2010)
125
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2011
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01086787
Other Study ID Numbers WTR-ECG-5
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party R.A. de Boer, MD, PhD, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Not Provided
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
PRS Account University Medical Center Groningen
Verification Date March 2010