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Clinical Trials/EUCTR2005-002706-27-GB
EUCTR2005-002706-27-GB
Active, not recruiting
Not Applicable

Randomised Control Trial To Compare The Effects Of G-CSF And Autologous Bone Marrow Progenitor Cells Infusion On Quality Of Life And Left Ventricular Function In Patients With Heart Failure Secondary to Ischaemic Heart Disease

Barts and the London NHS Trust, Department of Cardiology0 sites300 target enrollmentJune 15, 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart failure secondary to ischaemic heart disease
Sponsor
Barts and the London NHS Trust, Department of Cardiology
Enrollment
300
Status
Active, not recruiting
Last Updated
10 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 15, 2005
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Barts and the London NHS Trust, Department of Cardiology

Eligibility Criteria

Inclusion Criteria

  • Patients with a diagnosis of heart failure secondary to ischaemic heart disease attending the 'Heart Failure clinic' for optimisation of their heart failure medication or who are on optimal heart failure treatment under supervision from their physician
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • Recent acute coronary syndrome as judged by a rise of Troponin above normal values in the last 6 months
  • The presence of cardiogenic shock
  • The presence of acute left and/or right\-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
  • Known severe pre\-existent left ventricular dysfunction (ejection fraction \< 10% prior to randomisation)
  • Congenital cardiac disease
  • Cardiomyopathy 2o to a reversible cause e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia
  • Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
  • Contra\-indication for bone marrow aspiration
  • Known active infection
  • Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)

Outcomes

Primary Outcomes

Not specified

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