Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure (BM-CHF)
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure |
Other: Surgery |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure |
- Paracrine properties of bone marrow cells from patients with heart failure [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- To study preconditioning of different bone marrow stem cells with different cytokines [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To evaluate potential molecular mechanisms involved [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- To find mechanisms to enhance expansion of different bone marrow stem cells in vitro [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood, serum, white cells, urine, bone marrow
| Estimated Enrollment: | 125 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Non heart failure patients
Patients without heart failure undergoing open chest surgery
|
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery
|
|
Orthopedic patients
Patients without heart failure undergoing orthopedic surgery
|
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery
|
|
Heart failure patients
Patients with heart failure undergoing open chest surgery.
|
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: W. T. Ruifrok, MD | +31 50 361 61 61 ext 10248 | w.t.ruifrok@thorax.umcg.nl |
| Contact: R. A. de Boer, MD, PhD | +31 50 361 61 61 ext 15381 | r.a.de.boer@thorax.umcg.nl |
| Italy | |
| Department of Heart, Blood and Lung , University of Pavia | Not yet recruiting |
| Pavia, Italy | |
| Contact: M. Gnecchi, MD, PhD massimiliano.gnecchi@unipv.it | |
| Principal Investigator: M. Gnecchi, MD, PhD | |
| Netherlands | |
| University Medical Center Groningen | Not yet recruiting |
| Groningen, Netherlands, 9700 RB | |
| Contact: R. A. de Boer, MD, PhD +31 50 631 61 61 ext 15381 r.a.de.boer@thorax.umcg.nl | |
| Contact: W. T. Ruifrok, MD +31 50 631 61 61 ext 10248 w.t.ruifrok@thorax.umcg.nl | |
| Principal Investigator: W. T. Ruifrok, MD | |
| Principal Investigator: | W. T. Ruifrok, MD | University Medical Centre Groningen |
| Study Director: | R. A. de Boer, MD, PhD | University Medical Centre Groningen |
| Study Chair: | W. H. van Gilst, PhD | University Medical Centre Groningen |
| Study Director: | M. Gnecchi, MD, PhD | University of Pavia |
| Principal Investigator: | L. Kleijn, MD | University Medical Centre Groningen |
More Information
Additional Information:
No publications provided
| Responsible Party: | R.A. de Boer, MD, PhD, University Medical Center Groningen |
| ClinicalTrials.gov Identifier: | NCT01086787 History of Changes |
| Other Study ID Numbers: | WTR-ECG-5 |
| Study First Received: | March 12, 2010 |
| Last Updated: | June 10, 2010 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by University Medical Centre Groningen:
|
Heart failure Bone marrow Bone marrow mononuclear cells |
Surgery Orthopedic surgery Cardiac surgery |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013