Implementation
To achieve its goal SGLT2 HYPE has developed 15 thematic individual but closely connected work packages (WPs).
The project is guided by a strong project management team (WP14f) and supported by key preparatory activities, including networking, legal and ethical frameworks (WP1), data management system setup (WP2), patient engagement via eHealth tools (WP3), biobank preparation (WP4), and planning of statistical methods (WP5). The clinical core of the project focuses on patient enrolment, treatment, and study visits (WP6f), followed by comprehensive monitoring and data management (WP7f), leading into the project’s central statistical analysis (WP8). Building on these, the project explores the cost-effectiveness and health-economic impact (WP9), sex-specific and sociodemographic aspects (WP10), and investigates the biological mechanism of action of SGLT2 inhibitors in hypertension through biomarker analysis (WP11). Cross-cutting activities ensure effective communication and dissemination (WP13f) and active engagement with stakeholders and future exploitation of results (WP12f). All work is conducted in line with stringent ethical standards (WP35).
The SGLT2 HYPE Workpackages
WP1: Network set-up and legal/ethics regulation
Work Package 1 focuses on ensuring full regulatory, ethical, and operational readiness for the SGLT2 HYPE clinical trial. Led by UKSH and supported by all recruiting partners, this work includes identifying and aligning with local regulatory frameworks, finalising participant insurance coverage, obtaining ethical and regulatory approvals (via CTIS and national bodies), and registering the trial in relevant international databases. Additionally, the importation of investigational medicinal products will comply with German legislation. To ensure high-quality and consistent trial execution, standard operating procedures (SOPs) will be implemented and supported by partner training across all clinical sites. Together, these tasks establish a strong foundation for a compliant, efficient, and ethically sound trial launch.
Objectives:
- To obtain necessary approvals from national regulatory authorities and allow initiation of the trial across all sites
- To implement SOPs for all network partners, focusing on trial protocols and data collection methods to ensure consistency and high-quality data across all sites
WP Leader:
UKSH
Involved Partners:
MUI, VFNP, IIS-FJD, IRCCS, VULSK, GPRI, NIKARD, U.PORTO, UKCL, BNMU
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At a glance
Implementation
