Clinical Trial Search

Primary: 12-month Change in Myocardial Strain — 2.2; 1.0 percent change in heart dimension

Primary: Incidence of Treatment-Emergent Adverse Events — 14; 9; 10 Participants

Primary: Cardiac Ejection Fraction as Measured by Echocardiogram — 54.6; 55.2 percentage of blood leaving the heart

Primary: Number of Participants Experiencing Any of the Adjudicated Events — 0; 0; 0; 0 Participants

Primary: Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) — 15.1; 33.9; 20.6; 481.2 nM — p=0.0482

Primary: Left Ventricular Strain — 0.2; 0.4 Percent change in circumference — p=0.5867

Primary: The Relative Change in Peak Systolic Radial Strain of the Left Ventricle (LV) Inferolateral Wall From Baseline (at Screening) to Week 52, Assessed by Color Doppler…

Primary: Number of Participants With Adverse Events — 2; 1; 5; 4 Participants

Primary: Number of Subjects With an Adverse Event. — 1; 0; 0; 0 participants

Primary: Number of Participants With Adverse Events Related to AVI-4568 — 0; 0 Participants

Primary: Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity — -0.06; -0.21 cm/sec…

Primary: Difference in 6-Minute Walk Distance Between Groups (Control Minus IGF-1) for Change at 6 Months Versus Baseline — 3.4; -5.1 meters — p=0.53

Primary: Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month) — 4.8 units on a scale

Primary: Change From Baseline in 6MWD at Week 48 — -41.81; -12.86; -42.56 meters — p=0.4756

Primary: Myocyte Lipid Accumulation as Oil Red-O Positive Biopsie — 54; 21; 0 Endomyocardial Biopsies

Primary: Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs. — 1 Participants

Primary: Change in BMI — 0.67; 1.34; 1.8 kg/m^2

Primary: Number of Participants Experiencing Acute Respiratory Decompensation — 0; 0 Participants

Primary: Change From Baseline in 6MWD at Week 48 — -60.67; -47.69 meters — p=0.213

Primary: Body Composition (Body Fat) — 172.1; 232.7; 180.2; 274.8 g/Kg of body weight — p=<0.05

Primary: Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs) — 1; 0; 0; 1 Participants

Primary: Muscle, Nerve, or Vascular Damage — 16 participants

Primary: Percent Change in Range of Motion From Baseline to 180 Days — 67; 33 percentage of change

Primary: Change From Baseline in Muscle Function Using the 6 Minute Walking Distance (6MWD) Test Assessed at Week 48 — -52.65; -42.32 Meters — p=0.415

Primary: Heart Failure Mortality — 8; 19 participants — p=0.01

Primary: Mean Change From Baseline in Muscle Function Using the 6 Minute Walking Distance — -10.98; -19.93; 16.12 Meters — p=0.554

Primary: Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE) In Participants With Duchenne Muscular Dystrophy — 3; 5 Participants

Primary: Change in FVC (%-Predicted) From Baseline to 2 Years. — -9.2; -6.4 Mean difference in FVC %-predicted — p=0.68

Primary: Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52 — -8.84; -2.57 percentage

Primary: Improvement in Left Ventricular Ejection Fraction — 42.1; 37.6 Percentage — p=0.267