Delivering high quality data in a complex heart failure trial
Case study
Overview
CardioResearch is an academic cardiology research unit based at University Medical Centre Groningen (UMCG), one of Europe’s leading university hospitals. The team comprises cardiologists, physician‑scientists, and dedicated research staff with a focus on cardiovascular disease. Their portfolio includes both investigator‑initiated studies and collaborative projects with industry partners.
CardioResearch partnered with ICON to support a complex phase 1b–2a clinical trial in patients with heart failure with reduced ejection fraction (HFrEF), conducted at the ICON Clinical Research Unit (CRU) at the UMCG. Under this collaboration, CardioResearch maintained medical oversight of enrolled patients and supported recruitment, while ICON was responsible for trial execution in accordance with the protocol as one of the selected study sites. This shared‑responsibility approach laid the groundwork for a strong and highly effective partnership.
Challenge
From the start, it was evident that this was not a standard earlyphase study. The phase 1b/2a trial focused on patients with heart failure with reduced ejection fraction (HFrEF)- a population associated with significant clinical risk and strict eligibility criteria.
The HFrEF population carried a heightened risk of sudden clinical deterioration, and recruitment was anticipated to be challenging due to restrictive inclusion and exclusion criteria. Compounding this, the study was among the first early phase trials of its kind conducted at the ICON CRU at UMCG. The UMCG’s established expertise in heart failure was critical to enabling the study, while the combined teams successfully built the operational framework required to support this complex patient population.
Solution
ICON focused on anticipating the challenges of this study and prepared accordingly. Clinical leadership played a central role. Medical oversight of enrolled patients was provided by the cardiologists of CardioResearch at the UMCG, while ICON's Medical Director, a board-certified cardiologist, acted as Principal Investigator at the ICON site for trial execution. Together this ensured strong clinical governance and decision-making throughout the study.
Recruitment followed a carefully coordinated process. Eligible patients were identified and assessed at the UMCG. Patients who chose to participate, after full information and informed consent in accordance with applicable regulations, were enrolled at the ICON CRU. Relevant clinical information was shared between the teams with the patient's consent and in line with privacy legislation, with structured coordination and clearly defined medical responsibility throughout, ensuring continuity of care.
To further strengthen participant safety, intensive care nurses were engaged to ensure preparedness for potential emergencies. Drawing on the heart-failure expertise at the UMCG, detailed flowcharts and targeted training were developed to support the ICON study nurses in recognising and responding to relevant symptoms, ensuring the wider team was fully prepared for this patient population.
The Outcome
Through close collaboration and proactive operational planning, ICON successfully supported trial execution across multiple countries and sites:
- 8 patients enrolled at the UMCG site in a highly selective, multi‑country study that spanned the Netherlands, Sweden and the UK
- Part A: 5 patients
- Part B: 3 patients
- Safe and protocol‑compliant conduct in a patient population with elevated clinical risk
- Reliable delivery of high-quality clinical data supported by experienced teams and structured processes
The ICON team brought deep expertise in designing and delivering the study efficiently and to a high standard, drawing on extensive early phase experience to successfully manage the complexity of this trial. High‑quality data were supported through well‑structured protocols and experienced study teams, while proactive risk management—including clear escalation pathways and specialist clinical support—helped safeguard patient safety throughout execution. By streamlining study processes and investing in targeted, disease‑specific training for study staff, ICON reduced delays, improved consistency, and strengthened overall execution, supported by close coordination with CardioResearch to enable clear communication and effective delivery of the study.