Case Study | Cardiology & Heart Failure: Exceeded Enrollment Goal by 160% in Cardiology Clinical Trial

Profound Research’s embedded site model and integrated data access enabled exceptional enrollment performance in a complex cardiology study, surpassing goals by 160% and setting a new standard for operational excellence.

The study, a Phase 2 randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of an investigational product in adults with chronic heart failure, presented considerable challenges. Narrow inclusion criteria, frequent dosing visits, and complex cardiac assessments made identifying and retaining qualified patients especially difficult.

Through Profound’s embedded model within physician practices and direct access to the electronic medical record (EMR) database, our team rapidly identified eligible participants and streamlined the enrollment process. The ability to work directly within existing clinical environments allowed us to move quickly, maintain accuracy, and deliver a seamless experience for patients and sponsors alike.

The results were exceptional. Our site was the first activated globally, the first to screen, and the first to enroll a patient. Ultimately, the team randomized 16 participants, surpassing the initial goal of 10 and setting a high standard for performance and precision.

These outcomes highlight what makes Profound unique. By partnering directly with physicians and meeting patients where they already receive care, we deliver stronger enrollment performance, faster timelines, and greater data quality.

We are proud that the site’s contributions were recognized by the sponsor and CRO, culminating in the 2025 Site-Based Research Principal Investigator Award from the American Heart Association.

At Profound, every milestone reflects our commitment to finding solutions that advance research and improve lives. We continue to raise the bar for clinical trial execution, one study, one partnership, and one patient at a time.