Heart Failure Trial Echocardiography Core Lab

Challenge

In heart failure trials, ejection fraction and myocardial strain measurements frequently determine both eligibility and efficacy, yet echocardiography is among the most operator-dependent of imaging modalities. Across 75 sites, differences in image acquisition quality and measurement technique placed the LVEF, global longitudinal strain, and ventricular volume endpoints at risk. The sponsor required central assessment capable of delivering consistent, reproducible quantification from imaging acquired under real-world site conditions.

Our Solution

Intrinsic Imaging trained sonographers at every site on a standardized acquisition protocol, establishing a uniform foundation of image quality before central review began. Blinded central assessment of LVEF, global longitudinal strain, and ventricular volumes was then performed under a detailed measurement charter, with quality feedback returned to sites to sustain acquisition standards throughout enrollment and follow-up. This combination of upstream training and rigorous central measurement delivered endpoint data of consistent quality across the entire program.

Results

• Central assessment of 4100+ echocardiographic studies
• LVEF reader variability below 5%
• Endpoint data delivered on time for the primary analysis