Heart failure secondary to ischaemic heart disease. Circulatory System Heart failure
Conditions
Interventions
Daily subcutaneous injections of G-CSF at 10 µg/kg or placebo OR daily subcutaneous injections of G-CSF at 10 µg/kg followed by intracoronary injection of stem cells or placebo OR daily subcutaneous i
Sponsors
Barts and the London NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a diagnosis of heart failure secondary to ischaemic heart disease attending a heart failure clinic for optimisation of their heart failure medication or who are on optimal heart failure treatment under supervision from their physician.
Exclusion criteria
Exclusion criteria: 1. Recent acute coronary sydrome as judged by a rise of troponin above normal values in the last 6 months 2. The presence of cardiogenic shock 3. The presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema 4. Known severe pre-existent left ventricular dysfunction (ejection fraction 80% of the time 18. Serum creatinine >200 mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 6 months: 1. The change in global left ventricular ejection fraction (LVEF) at 6 months relative to baseline measured by quantitative left ventriculography 2. The change in regional wall motion score index at 6 months relative to baseline measured by tissue doppler imaging 3. The change in quality of life scores compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| At 6 months: 1. Death as result of the underlying cardiac condition 2. The occurence of major arrhythmias defined as ventricular tachycardia or survived sudden death 3. Presence of clinically evident heart failure 4. The change in global left ventricular ejection fraction at 6 months relative to baseline measured by resting echocardiography 4. The change in global and regional wall motion score index measured by resting echocardiography 5. Serum levels of amino-terminal pro-brain natriuretic peptide (NT-BNP) 6. Change in myocardial function as measured by magnetic resonance imaging (MRI) scanning (first 40 suitable patients in each group) 7. Change in voltage and shortening maps as assessed by NOGA (intramyocardial group only) At 12 months: 1. The occurrence of a major adverse cardiac event (MACE) 2. The change in left ventricular ejection fraction relative to baseline measured by resting echocardiography using Simpson's rule 3. The change in global and regional wall motion score index measured by resting echocardiography and tissue doppler imaging 4. Change in quality of life scores 5. Serum levels of amino-terminal pro-brain natriuretic peptide (NT-BNP) 5. Change in myocardial function as measured by MRI scanning (first 40 suitable patients in each group) | — |
Countries
United Kingdom
Outcome results
None listed