SEISMIC, 2011 trial summary

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

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 sizes 26 / 14



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



EndpointX1N1X0N0TE95% CI Minnesota Living With Heart Failure Questionnaire - 24 - 14 no data 6-min Walk, m - 19 - 13 no data all-cause mortality 1 26 0 14 1,62[0,06; 42,46] LVEF - 24 - 14 no data acute heart failure 3 24 1 14 1,36[0,18; 10,45] LV End-Systolic Volume - -9 - -9 no data ventricular tachycardia 6 26 3 14 1,00[0,22; 4,48] NT-proBNP - -9 - -9 no data NYHA deterioration 2 26 4 14 0,30[0,05; 1,67] Peak VO2 (mL/kg/min) - -9 - -9 no data NYHA class - -9 - -9 no data cardiac event - 26 - 14 no data0,22,01,0


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  



Registering number (see trial on clinicaltrials.gov)
Code Name

 




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