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passages: A double-blind , randomized , controlled , multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction . BACKGROUND We sought to determine the safety and preliminary efficacy of transcatheter intramyocardial administration of myoblasts in patients with heart failure ( HF ) . METHODS MARVEL is a randomized placebo-controlled trial of image-guided , catheter-based intramyocardial injection of placebo or myoblasts ( 400 or 800 million ) in patients with class II to IV HF and ejection fraction < 35 % . Primary end points were frequency of serious adverse events ( safety ) and changes in 6-minute walk test and Minnesota Living With HF score ( efficacy ) . Of 330 patients intended for enrollment , 23 were randomized ( MARVEL-1 ) before stopping the study for financial reasons . RESULTS At 6 months , similar numbers of events occurred in each group : 8 ( placebo ) , 7 ( low dose ) , and 8 ( high dose ) , without deaths . Ventricular tachycardia responsive to amiodarone was more frequent in myoblast-treated patients : 1 ( placebo ) , 3 ( low dose ) , and 4 ( high dose ) . A trend toward improvement in functional capacity was noted in myoblast-treated groups ( Δ6-minute walk test of -3.6 vs +95.6 vs +85.5 m [ placebo vs low dose vs high dose ; P = .50 ] ) without significant changes in Minnesota Living With HF scores . CONCLUSIONS In HF patients with chronic postinfarction cardiomyopathy , transcatheter administration of myoblasts in doses of 400 to 800 million cells is feasible and may lead to important clinical benefits . Ventricular tachycardia may be provoked by myoblast injection but appears to be a transient and treatable problem . A large-scale outcome trial of myoblast administration in HF patients with postinfarction cardiomyopathy is feasible and warranted .
entities: 2269
entities: Intervention_Pharmacological
entities: skeletal myoblast implantation
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entities: Intervention_Pharmacological
entities: myoblasts
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entities: Intervention_Control
entities: placebo
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entities: Intervention_Pharmacological
entities: myoblasts
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entities: Intervention_Control
entities: ( placebo )
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entities: Intervention_Pharmacological
entities: myoblast-treated
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entities: Intervention_Control
entities: ( placebo )
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entities: Intervention_Pharmacological
entities: myoblast-treated
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entities: Intervention_Pharmacological
entities: myoblasts
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entities: Outcome_Other
entities: safety
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entities: Outcome_Physical
entities: cardiovascular effects
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entities: Outcome_Other
entities: safety
entities: 2281
entities: Outcome_Other
entities: efficacy
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entities: Outcome_Adverse-effects
entities: frequency of serious adverse events (
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entities: Outcome_Other
entities: safety
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entities: Outcome_Adverse-effects
entities: )
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entities: Outcome_Physical
entities: changes in 6-minute walk test
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entities: Outcome_Physical
entities: Minnesota Living With HF score
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entities: Outcome_Adverse-effects
entities: (
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entities: Outcome_Other
entities: efficacy
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entities: Outcome_Adverse-effects
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entities: Outcome_Physical
entities: Ventricular tachycardia responsive
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entities: Outcome_Physical
entities: functional capacity
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entities: Participant_Condition
entities: patients with chronic heart failure after myocardial infarction .
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entities: Participant_Condition
entities: patients with heart failure ( HF ) .
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entities: Participant_Condition
entities: patients with class II to IV HF and ejection fraction < 35 % .
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entities: Participant_Sample-size
entities: 330
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entities: Participant_Sample-size
entities: 23