How Profound’s embedded cardiology model, direct EMR access, and physician engagement supported enrollment in a complex rare-disease cardiovascular trial
Identifying and enrolling patients with transthyretin amyloid cardiomyopathy (ATTR-CM) presents a significant challenge. The condition is rare and underdiagnosed, while clinical trial participation can require stringent diagnostic confirmation and demanding study procedures.
For one global Phase III cardiovascular outcomes trial, those challenges included frequent long-duration IV infusions, extensive imaging and functional assessments, and an aggressive startup timeline.
Working within a high-volume cardiology practice, Profound Research combined direct EMR access, proactive patient identification, engaged physicians, and coordinated study procedures to help navigate that complexity.
The result: First Patient Treated globally.
The Challenge: A Rare Population and Demanding Protocol
Recruiting participants for an ATTR-CM trial begins with identifying patients within an inherently narrow population. Because ATTR-CM is rare and underdiagnosed, finding appropriate candidates requires careful patient identification followed by stringent diagnostic confirmation.
The protocol added another layer of complexity. Participants faced frequent, long-duration IV infusions along with extensive imaging and functional assessments. Together, these requirements created a demanding treatment schedule for both patients and the research team.
Within an aggressive startup timeline, the site needed to identify appropriate candidates efficiently while coordinating the diagnostic and procedural requirements necessary to move qualified participants through screening and toward treatment.
The Solution: Embedded Research and Proactive Patient Identification
Profound’s embedded model placed the research team within a high-volume cardiology practice, providing direct EMR access that could be used to proactively identify potentially eligible patients.
Physician engagement played an important role in the process. Physicians viewed the study as an important treatment option, understood the inclusion criteria, and referred appropriate candidates early.
Once potential participants were identified, the research team proactively coordinated imaging review, laboratory confirmation, and infusion scheduling. This integrated approach helped streamline screening and minimize delays as patients progressed toward randomization.
By combining access to an established cardiology patient population with physician knowledge and coordinated research operations, the team was positioned to execute a complex protocol efficiently.
The Outcome: First Patient Treated Globally
The site successfully identified and enrolled a fully eligible patient within the narrow ATTR-CM population, ultimately achieving First Patient Treated globally.
Key Study Achievements:
- Site Activation: September 24, 2025
- First Patient Screened Globally: December 3, 2025
- First Patient Treated Globally: February 4, 2026
The achievement reflected strong protocol execution and operational readiness in a complex rare-disease cardiovascular study, highlighting Profound’s experience enrolling patients in demanding cardiovascular trials.
What This Means for Sponsors
Rare-disease cardiovascular trials require more than access to patients. Success depends on the ability to identify potentially eligible participants within a narrow population, collaborate closely with physicians, and efficiently coordinate the complex diagnostic and procedural requirements of the protocol.
This case demonstrates the value of Profound’s embedded research model in that environment. Direct EMR access supported proactive patient identification, physician familiarity with the inclusion criteria helped surface appropriate candidates early, and coordinated imaging, laboratory confirmation, and infusion scheduling helped minimize delays during screening.
For sponsors conducting complex cardiovascular trials, integrating research operations within established physician practices can provide the patient access, clinical collaboration, and operational coordination needed to move studies forward.
Looking Ahead
Complex cardiovascular trials demand precision at every stage—from identifying the right patients to coordinating the procedures required to move them through screening and treatment.
In this global Phase III ATTR-CM trial, Profound’s embedded model brought those capabilities together within an established cardiology practice. The result—First Patient Treated globally—demonstrates what strong physician engagement, proactive patient identification, and coordinated research operations can achieve in a challenging rare-disease population.
At Profound Research, that combination of patient access, physician partnership, and operational execution continues to support the advancement of complex cardiovascular research