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

NCT01086787 | Unknown

• 1 other identifier: WTR-ECG-5
• Study Type: observational
• Target: 125
• Locations: 2 countries
• Sites: 2

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

Keywords

Heart failure; Bone marrow; Bone marrow mononuclear cells; Surgery; Orthopedic surgery; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• To study preconditioning of different bone marrow stem cells with different cytokines

  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

  1 day

• To evaluate potential molecular mechanisms involved

  1 day

• To find mechanisms to enhance expansion of different bone marrow stem cells in vitro

  1 day

Study Arms (3)

Non heart failure patients

Patients without heart failure undergoing open chest surgery

Other: Surgery

Orthopedic patients

Patients without heart failure undergoing orthopedic surgery

Other: Surgery

Heart failure patients

Patients with heart failure undergoing open chest surgery.

Other: Surgery

Interventions

Surgery OTHER

Patients undergoing surgery for either cardiac surgery or orthopedic surgery

Heart failure patients; Non heart failure patients; Orthopedic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• For all participants:
• Before any study-specific procedures, the appropriate written informed consent must be obtained.
• Male and female older than 18 years of age.
• For the cardiac patients:
• Being accepted for cardiothoracic surgery with the use of open chest surgery
• 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:
• Accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery.

You may not qualify if:

• 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).
• Younger than 18 years of age.
• Clinical history of chronic kidney disease (at any point prior to registration).
• Any known hepatic disease.
• Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
• Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period.
• Participation in any investigational device or drug trial(s) or receiving investigational agent(s) within 30 days.
• 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.
• Legally incompetent adults, for which reason what so ever.
• For the non-cardiac patients:
• A known history of cardiovascular disease.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (2)

Department of Heart, Blood and Lung , University of Pavia

Pavia, Italy

Location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Heart Failure

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• W. T. Ruifrok, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• R. A. de Boer, MD, PhD

  University Medical Center Groningen

  STUDY DIRECTOR

• W. H. van Gilst, PhD

  University Medical Center Groningen

  STUDY CHAIR

• M. Gnecchi, MD, PhD

  University of Pavia

  STUDY DIRECTOR

• L. Kleijn, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

W. T. Ruifrok, MD

CONTACT

+31 50 361 61 61; w.t.ruifrok@thorax.umcg.nl

R. A. de Boer, MD, PhD

CONTACT

+31 50 361 61 61; r.a.de.boer@thorax.umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 11, 2010

Record last verified: 2010-03

Locations

NL (1); IT (1)