The primary endpoint was left ventricular end systolic volume
(LVESVI) at one-year, assessed using a Wilcoxon rank sum test categorizing deaths as the lowest LVESVI rank.
The primary results, published in the April 25, 2013, edition of The New England Journal of Medicine, showed a 26 percent relative risk reduction in the composite of death, healthcare utilization visits requiring intravenous heart failure therapy, and significant increase in LV end systolic volume
among patients receiving BiV pacing.
End systolic volume
: End systolic volume
(ESV) refers to the volume of blood left in the ventricle following a contraction.
Additional results from the BLOCK HF trial demonstrated a 26% relative risk reduction in the composite of death, healthcare utilization visits requiring IV heart failure therapy, and significant increase in left ventricular end systolic volume
index (LVESVi a measure of cardiac function) among patients receiving BiV pacing, meeting the trial's primary objective.
After 180 days from treatment, the TMZ group showed a smaller end systolic volume
than the placebo group (echocardiographic data), 46.
Efficacy domains included symptomatic changes in NYHA class and the MLHF (Minnesota Living With Heart Failure) questionnaire; functional changes based on 6-minute walk test and maximal oxygen consumption; changes in N-terminal prohormone brain natriuretic peptide; and evidence of remodeling based on ejection fraction scores and end systolic volume
Efficacy endpoints determined from cardiac MRI include end systolic volume
, LVEF and the ability of Prochymal to preserve functional heart tissue and limit scar formation following a heart attack.
These beneficial changes in cardiacfunction resulted chiefly from a significant reduction in LV end systolic volume
from 59 mL to 53 mL in the group with a baseline EF of 35% or less, and from 55 mL to 50 mL in patients with a baseline EF above 35%.
Left ventricular ejection fraction was calculated as the difference between end-diastolic and end systolic volume
divided by end-diastolic volume (13).
The trial demonstrated a statistically significant reduction in heart size (left ventricular end systolic volume
index, or LVESVi), as measured by cardiac ultrasound, improving its function and helping the heart pump more efficiently in patients receiving CRT (p<0.
The primary endpoint at six months will be change, compared to baseline, in LV end systolic volume
as measured by cardiac computed tomography.
BL-1040 was shown to prevent wall thinning and stabilize End Systolic Volume
(ESV) and Ejection Fraction (EF).