MARVEL, 2011 trial summary

A randomised clinical trial investigating the effect of myoblasts versus placebo in patients with class II to IV HF and ejection fraction <35%

NCT00526253    Am Heart J 2011;162:654-662.e1  




Studied treatment image-guided, catheter-based intramyocardial injection of placebo or myoblasts (400 or 800 million)
Control treatment placebo
cell type Bone marrow mononuclear cells
Cell injection procedure Endomyocardial



Patients patients with class II to IV HF and ejection fraction <35%
Group sizes 14 / 6



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



EndpointX1N1X0N0TE95% CI LV End-Systolic Volume - -9 - -9 no data ventricular tachycardia 6 13 1 6 Out of scale2,77[0,25; 30,77] NT-proBNP - -9 - -9 no data NYHA deterioration - -9 - -9 no data Peak VO2 (mL/kg/min) - -9 - -9 no data NYHA class - -9 - -9 no data cardiac event - 14 - 6 no data Minnesota Living With Heart Failure Questionnaire - -9 - -9 no data 6-min Walk, m - 13 - 6 no data all-cause mortality - -9 - -9 no data LVEF - -9 - -9 no data acute heart failure 3 13 0 6 Out of scale3,23[0,14; 74,93]0,22,01,0


Povsic TJ, O'Connor CM, Henry T, Taussig A, Kereiakes DJ, Fortuin FD, Niederman A, Schatz R, Spencer R 4th, Owens D, Banks M, Joseph D, Roberts R, Alexander JH, Sherman W 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. Am Heart J 2011;162:654-662.e1     [PMID: 21982657]   link to pdf  



Registering number NCT00526253 (see trial on clinicaltrials.gov)
Code Name

 




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