SEISMIC, 2011 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of myoblasts versus control in Patienst with heart failure patients with implanted cardioverter-defibrillators

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EuroIntervention 2011;6:805-12  



Studied treatment percutaneous intramyocardial transplantation of autologous skeletal myoblasts
Control treatment control
cell type Skeletal myoblasts
Cell injection procedure Endomyocardial



Patients Patienst with heart failure patients with implanted cardioverter-defibrillators
Group sizes26 / 14



Blindness Inclusion period
Follow-up duration 6 mo Centers
Lost to FU geographical localisation
Primary endpoint Design



EndpointX1N1X0N0TE95% CI NYHA deterioration 2 26 4 14 0,27[0,04; 1,71] LVEF - 24 - 14 no data Peak VO2 (mL/kg/min) - -9 - -9 no data acute heart failure 3 24 1 14 1,75[0,16; 18,66] cardiac event - 26 - 14 no data NYHA class - -9 - -9 no data LV End-Systolic Volume - -9 - -9 no data Minnesota Living With Heart Failure Questionnaire - 24 - 14 no data ventricular tachycardia 6 26 3 14 1,08[0,22; 5,17] 6-min Walk, m - 19 - 13 no data NT-proBNP - -9 - -9 no data all-cause mortality 1 26 0 14 1,62[0,06; 42,46]0,22,01,0

Duckers HJ, Houtgraaf J, Hehrlein C, Schofer J, Waltenberger J, Gershlick A, Bartunek J, Nienaber C, Macaya C, Peters N, Smits P, Siminiak T, van Mieghem W, Legrand V, Serruys PW Final results of a phase IIa, randomised, open-label trial to evaluate the percutaneous intramyocardial transplantation of autologous skeletal myoblasts in congestive heart failure patients: the SEISMIC trial. EuroIntervention 2011;6:805-12     [PMID: 21252013]   link to pdf   add to Mendeley  



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