Case Study: Leading Hypertrophic Cardiomyopathy (HCM) Service Provider achieves regulatory approval in Phase III HOCM trial with Perceptive

Navigating Imaging Complexity in Phase III HOCM Clinical Trial

Leading Hypertrophic Cardiomyopathy (HCM) Service Provider ran a complex Phase III HOCM trial across 15 sites (130 screened, 81 enrolled) that required both echocardiography and cardiac MRI to support eligibility, dosing and efficacy endpoints. They faced challenges harmonizing multi‑site image acquisition (including echo with Valsalva maneuvers), standardizing advanced CMR sequences, and minimizing reader variability to generate regulatory‑quality imaging data. Perceptive (Perceptive Imaging) was engaged to manage these imaging needs.

Perceptive implemented customized echo and CMR acquisition protocols, trained site sonographers and optimized scanner‑specific MRI sequences, recruited and trained expert independent cardiologist reviewers, and monitored reviewer performance and data quality throughout the study. These measures streamlined reviewer workflows and reduced reader‑to‑reader variability to acceptable levels, enabling timely independent analyses that supported database lock, NDA submission, a successful on‑site inspection and ultimately regulatory approval of the compound — which has since been licensed to a global pharmaceutical company. Perceptive’s involvement was central to achieving these pivotal milestones.