Heart failure
Conditions
Brief summary
Part A (Dose Escalation steps): Adverse events related to the procedure, including in particular arrhythmic events and worsening of disease progression within 28 days (based on a comparison of data obtained during visit 2 and visit 7), Part B: Adverse events related to the procedure, including in particular arrhythmic events and worsening of disease progression within the whole study duration, Evidence for structural and functional muscular augmentation of target myocardium determined as enhanced target heart wall thickness (HWT) and thickening fraction (HWTF)
Detailed description
Frequency of major adverse cardiac events (MACE; non-fatal myocardial infarction, non-fatal stroke and cardiovascular death), Frequency and severity of arrhythmic events, Incidence of immune rejection (allograft DNA, CK/CK-MB, cTnT. DSA), Incidence of mechanical perturbation of ventricular function by EHM graft, Recurrent HF hospitalizations, Left ventricular ejection fraction (EF), Change in heart failure medication, Functional status in patients as determined by cardiopulmonary stress testing (VO2max), six-minute walk test (6MWT), and hand-grip strength measurements, Patient reported outcomes assessed by NYHA classification, quality of life score (KCCQ, EQ-5D, QoL-VAD), and study adherence motivation (PHQ-9, HAF-17, ESSI, LOT-R, ULS-8, medication adherence, Trust/Mistrust in medical staff), All-cause and cardiovascular mortality
Interventions
DRUGEngineered Human Myocardium (EHM)
Sponsors
Universitaetsmedizin Goettingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A (Dose Escalation steps): Adverse events related to the procedure, including in particular arrhythmic events and worsening of disease progression within 28 days (based on a comparison of data obtained during visit 2 and visit 7), Part B: Adverse events related to the procedure, including in particular arrhythmic events and worsening of disease progression within the whole study duration, Evidence for structural and functional muscular augmentation of target myocardium determined as enhanced target heart wall thickness (HWT) and thickening fraction (HWTF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of major adverse cardiac events (MACE; non-fatal myocardial infarction, non-fatal stroke and cardiovascular death), Frequency and severity of arrhythmic events, Incidence of immune rejection (allograft DNA, CK/CK-MB, cTnT. DSA), Incidence of mechanical perturbation of ventricular function by EHM graft, Recurrent HF hospitalizations, Left ventricular ejection fraction (EF), Change in heart failure medication, Functional status in patients as determined by cardiopulmonary stress testing (VO2max), six-minute walk test (6MWT), and hand-grip strength measurements, Patient reported outcomes assessed by NYHA classification, quality of life score (KCCQ, EQ-5D, QoL-VAD), and study adherence motivation (PHQ-9, HAF-17, ESSI, LOT-R, ULS-8, medication adherence, Trust/Mistrust in medical staff), All-cause and cardiovascular mortality | — |
Countries
Germany
Outcome results
None listed