Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure (BM-CHF)
Recruitment status was Not yet recruiting
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| First Received Date ICMJE | March 12, 2010 | ||||||||||||||||||||
| Last Updated Date | June 10, 2010 | ||||||||||||||||||||
| Start Date ICMJE | August 2010 | ||||||||||||||||||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01086787 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure | ||||||||||||||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood, serum, white cells, urine, bone marrow |
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| 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. |
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| Condition ICMJE | Heart Failure | ||||||||||||||||||||
| Intervention ICMJE | Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery |
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| Publications * | Not Provided | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 125 | ||||||||||||||||||||
| Estimated Completion Date | December 2011 | ||||||||||||||||||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: For all participants:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy, Netherlands | ||||||||||||||||||||
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| NCT Number ICMJE | NCT01086787 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | WTR-ECG-5 | ||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||
| Responsible Party | R.A. de Boer, MD, PhD, University Medical Center Groningen | ||||||||||||||||||||
| Study Sponsor ICMJE | University Medical Centre Groningen | ||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University Medical Centre Groningen | ||||||||||||||||||||
| Verification Date | March 2010 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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