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

• ClinicalTrials.gov Identifier: NCT01086787
• Recruitment Status: Unknown
• First Posted: March 15, 2010
• Last Update Posted: June 11, 2010
• Sponsor: University Medical Center Groningen
• 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

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

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

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