CClinicalTrials.gg
Status unknownNCT01086787BM-CHFUpdated Jun 11, 2010

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

An observational study in Heart Failure, sponsored by University Medical Center Groningen. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-11.

Sponsored by University Medical Center Groningen · Observational

The sponsor has not verified this record recently (last verified Mar 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
125
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Heart failure
  • Bone marrow
  • Bone marrow mononuclear cells
  • Surgery
  • Orthopedic surgery
  • Cardiac surgery
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 125 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
125 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherSurgery

    Patients undergoing surgery for either cardiac surgery or orthopedic surgery

06

What researchers measure

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.

    Time frame: 1 day

Secondary outcomes

  1. To study preconditioning of different bone marrow stem cells with different cytokines

    Time frame: 1 day

  2. 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

  3. To evaluate potential molecular mechanisms involved

    Time frame: 1 day

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

    Time frame: 1 day

07

Study locations

2 sites
  • Department of Heart, Blood and Lung , University of Pavia
    Pavia, Italy
  • University Medical Center Groningen
    Groningen, 9700 RB, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01086787
Lead sponsor
University Medical Center Groningen
First posted
Mar 15, 2010
Start date
Aug 2010
Primary completion
Aug 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Jun 11, 2010

Study contacts

W. T. Ruifrok, MD
Contact
w.t.ruifrok@thorax.umcg.nl
+31 50 361 61 61 ext. 10248
R. A. de Boer, MD, PhD
Contact
r.a.de.boer@thorax.umcg.nl
+31 50 361 61 61 ext. 15381
W. T. Ruifrok, MD
principal investigator · University Medical Center Groningen
R. A. de Boer, MD, PhD
study director · University Medical Center Groningen
W. H. van Gilst, PhD
study chair · University Medical Center Groningen
M. Gnecchi, MD, PhD
study director · University of Pavia
L. Kleijn, MD
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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