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

NCT ID: NCT01086787

Last Updated: 2010-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-12-31

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non heart failure patients

Patients without heart failure undergoing open chest surgery

Surgery

Intervention Type: OTHER

Patients undergoing surgery for either cardiac surgery or orthopedic surgery

Orthopedic patients

Patients without heart failure undergoing orthopedic surgery

Surgery

Intervention Type: OTHER

Patients undergoing surgery for either cardiac surgery or orthopedic surgery

Heart failure patients

Patients with heart failure undergoing open chest surgery.

Surgery

Intervention Type: OTHER

Patients undergoing surgery for either cardiac surgery or orthopedic surgery

Interventions

Surgery

Patients undergoing surgery for either cardiac surgery or orthopedic surgery

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

University Medical Center Groningen

Principal Investigators

W. T. Ruifrok, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

R. A. de Boer, MD, PhD

Role: STUDY_DIRECTOR

University Medical Center Groningen

W. H. van Gilst, PhD

Role: STUDY_CHAIR

University Medical Center Groningen

M. Gnecchi, MD, PhD

Role: STUDY_DIRECTOR

University of Pavia

L. Kleijn, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

Department of Heart, Blood and Lung , University of Pavia

Pavia, , Italy

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Italy; Netherlands

Central Contacts

W. T. Ruifrok, MD

Role: CONTACT

w.t.ruifrok@thorax.umcg.nl

+31 50 361 61 61 ext. 10248

R. A. de Boer, MD, PhD

Role: CONTACT

r.a.de.boer@thorax.umcg.nl

+31 50 361 61 61 ext. 15381

Facility Contacts

M. Gnecchi, MD, PhD

Role: primary

massimiliano.gnecchi@unipv.it

R. A. de Boer, MD, PhD

Role: primary

r.a.de.boer@thorax.umcg.nl

+31 50 631 61 61 ext. 15381

W. T. Ruifrok, MD

Role: backup

w.t.ruifrok@thorax.umcg.nl

+31 50 631 61 61 ext. 10248

Other Identifiers

WTR-ECG-5

Identifier Type: -

Identifier Source: org_study_id