ERT provided cardiac imaging and echocardiography solutions for a mid-sized pharmaceutical company running Phase III and IV studies for a new therapy to treat obesity.
The Role of ERT Cardiac Imaging in the Study
The sponsor was involved in a large set of clinical studies focusing on a new therapy to treat obesity. The sponsor required a uniquely experienced imaging partner to help monitor the safety of their compound being studied at 250 study sites spanning the U.S and Canada.
Due to the recent history of other obesity treatment compounds (e.g., fen-phen) causing harm to the heart, both the FDA and the sponsor required precise monitoring for potential cardiovascular adverse effects. The sponsor turned to ERT for its deep expertise in cardiac imaging and echocardiography.
ERT developed and utilized an imaging protocol tailored specifically to the study with precise controls based on the prior expertise of its clinical leaders and cardiology experts. With study-specific image acquisition and image interpretation precision controls in place, ERT was able to generate reproducible and accurate results across all study sites, leading to high satisfaction from the sponsor.
ERT’s Cardiac Imaging Solution
By engaging ERT to support the imaging needs for these obesity clinical trials, the sponsor was able to:
- Successfully manage studies for a compound as it was being sold from one pharmaceutical company to another
- Successfully execute a study comprising 250 sites spanning two countries
- Successfully process and measure nearly 20,000 separate echocardiograms
- Compile and process 45,000+ echo image analysis reports
- Report zero significant compound-related patient indications of valvulopathy, including valvular regurgitation
- Report zero significant compound-related patient indications of increased pulmonary hypertension
- Support treatment safety and efficacy claims through high-quality data and accurate imaging measurements