How early patient pre-screening, an embedded cardiology model, and strong physician relationships helped drive global-first milestones and sustained enrollment performance
Heart failure clinical trials can present significant recruitment challenges, particularly when narrow eligibility criteria and demanding study requirements limit the pool of appropriate participants.
For one cardiology clinical trial, frequent dosing visits and extensive cardiac assessments added to that complexity, while the sponsor’s tight startup and recruitment timeline placed additional pressure on the site to identify and enroll qualified patients efficiently.
Profound Research began preparing before enrollment opened. Leveraging its embedded model within physician practices and access to the EMR database, the team conducted patient pre-screening and visit planning between site selection and activation.
The site went on to become the first site activated globally, first to screen a patient globally, and first to enroll a patient globally—ultimately randomizing 16 participants and exceeding its original enrollment goal by 160%
The Challenge: Finding the Right Patients Within a Demanding Timeline
Identifying qualified heart failure patients was only part of the challenge.
Narrow inclusion criteria reduced the pool of potential participants, while frequent dosing visits and extensive cardiac assessments created additional demands throughout study participation. Together, these factors made identifying, enrolling, and retaining qualified patients particularly challenging.
At the same time, the sponsor was working within a tight startup and recruitment timeline, making early preparation and efficient patient identification especially important.
The Solution: Pre-Screening Before Enrollment
Following site selection on February 7, Profound began patient pre-screening and visit planning ahead of site activation.
Working within physician practices and using access to the EMR database, the team conducted pre-screening searches to identify potential participants before enrollment opened. This preparation enabled screening visits to be prescheduled so the team could begin recruitment quickly once the site was activated.
Strong physician relationships further supported patient identification, while Profound’s embedded operational model helped streamline the process from pre-screening through enrollment.
On March 29, the site became the first site activated globally for the trial.
Just five days later, on April 3, it became the first site to screen a patient globally.
The Outcome: 160% Above the Original Enrollment Goal
The site’s early momentum continued after activation.
On April 30, Profound became the first site to enroll a patient globally. The site also became the first to enroll four patients globally, demonstrating that its initial enrollment performance extended beyond a single participant.
By the end of enrollment, the site had randomized 16 participants, exceeding its original enrollment goal by 160% and positioning Profound as a top-performing site across the study.
Key Study Achievements:
- Exceeded the original enrollment goal by 160%
- Randomized 16 participants
- First site activated globally
- First site to screen a patient globally
- First site to enroll a patient globally
- First site to enroll four patients globally
- Principal Investigator received the 2025 Site-Based Research Principal Investigator Award from the American Heart Association for their contribution to the trial
Study Timeline:
- February 7: Site selected
- February 7–March 29: Patient pre-screening and visit planning
- March 29: Site activated — first site activated globally
- April 3: First patient screened globally
- April 30: First patient enrolled globally
What This Means for Sponsors
Strong enrollment performance often begins before a site is activated.
In this heart failure trial, Profound used the period between site selection and activation to identify potential participants through EMR-based pre-screening and prepare screening visits in advance. When activation occurred, the team was positioned to begin screening quickly rather than starting patient identification from the beginning.
That preparation contributed to a series of global-first milestones, but more importantly, the site’s performance continued throughout recruitment. Randomizing 16 participants and exceeding the original enrollment goal by 160% demonstrates how early patient identification, physician relationships, and streamlined site operations can translate into sustained enrollment performance.
For sponsors working within tight recruitment timelines, the case illustrates the value of pairing access to an appropriate patient population with operational preparation before enrollment begins.
Looking Ahead
Successful enrollment in complex cardiology trials requires more than identifying potential participants. Sites must be able to find qualified patients, prepare for demanding study requirements, and maintain the operational efficiency necessary to support enrollment and retention.
In this heart failure trial, Profound’s embedded model, EMR access, physician relationships, and early pre-screening helped the site establish momentum before activation and sustain it throughout recruitment.
From becoming the first site activated globally to ultimately exceeding its enrollment goal by 160%, the results demonstrate the impact of preparation, collaboration, and consistent execution in cardiovascular clinical research.