Evaluation of Circulating Levels of Adult Stem Cells in the Peripheral Blood of Patients With Acute Decompensated Heart Failure and Following Stabilization, in Comparison With Healthy Volunteers

NCT01027403 | Completed

• 1 other identifier: 234/07
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Despite advances in medical technology, heart failure remains a major cause of illness on a global scale. Medical research, over recent years, has shown that adult stem cells (as opposed to embryonic stem cells) are present in most organs of adult humans. Their exact function is however poorly understood. An improved understanding of what these stem cells do and how they work is essential if effective stem cell treatments are to be developed in future. The project seeks to examine the levels of a number of different types of stem cells in patients with heart failure, compared to healthy volunteers. The project also aims to measure stem cell levels in patients with heart failure at the time of a sudden worsening in their condition and then later in the same patients following recovery. The project entails the taking of blood samples in order to measure the stem cell levels in the blood. The study does NOT involve any form of treatment with stem cells. Two groups of patients will be studied; patients with heart failure and healthy volunteers.

Conditions

Heart Failure

Keywords

Heart failure; Adult stem cells; Circulating stem cells; Acute decompensated heart failure

Outcome Measures

Primary Outcomes (1)

• Change in circulating levels of adult stem cells in the peripheral blood of patients with acute decompensated heart failure and following stabilization, in comparison with healthy volunteers.

  Baseline and following stablization of heart failure

Study Arms (2)

Healthy volunteers

Acute decompensated heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute decompensated heart failure and healthy volunteers.

You may qualify if:

• Men or women 18 years or older
• Hospitalized for the management of ADHF or diagnosed with ADHF within 48 hours after being hospitalized for another reason (patients/cases ONLY)
• Signed (by the subjects or their legally acceptable representatives) informed consent

You may not qualify if:

• Hospitalized for \> 48 hours before study enrollment
• Likely to be discharged from the hospital in 24 hours or less
• Current haematological disorder or haematological malignancy
• Active infection / sepsis
• Major organ insufficiency (other than heart failure in heart failure patients)
• Pregnancy
• Healthy volunteers found to have signs and/or symptoms of heart failure on screening.

Sponsors & Collaborators

• Monash University: lead
• The Alfred: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Henry Krum, MBBS FRACP PhD

  Monash University / Alfred Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 8, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2014
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

AU (1)