Heart failure secondary to ischaemic heart disease
Conditions
Interventions
Trade Name: GRANOCYTE
Pharmaceutical Form:
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
Product Name: autologous mononuclear cells
Pharmace
Sponsors
Barts and the London NHS Trust, Department of Cardiology
Eligibility
Sex/Gender
All
Inclusion 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
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 80% of the time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether peripheral mobilisation of autologous stem cells and intracardiac administration of the mononuclear fraction of bone marrow derived cells will lead to an improvement in symptoms and cardaic function in patients with heart failure;Secondary Objective: To assess the cost implications of such a procedure.;Primary end point(s): The change in global left ventricular ejection fraction (LVEF) at 6 months relative to baseline measured by quantitative left ventriculography (QLV). The change in regional wall motion score index at 6 months relative to baseline measured by tissue doppler imaging. The change in quality of life scores compared to baseline. | — |
Countries
United Kingdom
Outcome results
None listed