Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure

Heart Failure Clinical Trial

— BM-CHF  

Official title:

Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01086787
• Other study ID #: WTR-ECG-5
• Status: Not yet recruiting
• Phase: N/A
• First received: March 12, 2010
• Last updated: June 10, 2010
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2010
• Source: University Medical Center Groningen
• Contact: W. T. Ruifrok, MD
• Phone: +31 50 361 61 61
• Email: w.t.ruifrok[@]thorax.umcg.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery

Locations

Country	Name	City	State
Italy	Department of Heart, Blood and Lung , University of Pavia	Pavia
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Countries where clinical trial is conducted

Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day	No
Secondary	To study preconditioning of different bone marrow stem cells with different cytokines		1 day	No
Secondary	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		1 day	No
Secondary	To evaluate potential molecular mechanisms involved		1 day	No
Secondary	To find mechanisms to enhance expansion of different bone marrow stem cells in vitro		1 day	No

External Links

•   Official website of the UMCG