During the first reporting period (1 January 2025 to 30 June 2026), the consortium moved from project set-up into active clinical implementation. It finalised the trial protocol and statistical framework, prepared harmonised participant information and consent materials, and established the required ethics, regulatory, safety and monitoring procedures. By the reporting cut-off, six countries had regulatory approval and 13 sites were open for recruitment.
A study-specific route for manufacture, third-country import, independent quality release, storage and distribution of blinded dapagliflozin and matching placebo was successfully established. This required additional regulatory clarification and contributed to recruitment starting later than planned, but the operational pathway is a major achievement for this investigator-initiated trial. The first participant was randomised on 12 December 2025. By 30 June 2026, 72 participants had been randomised across five centres and all had received their initial study-medication supply; 33 had completed the eight-week safety visit and three the six-month visit. Recruitment recovery measures include faster activation and support of additional centres, structured pre-screening, clearly assigned recruitment responsibilities, regular site-performance calls and rapid escalation of local barriers. The planned 36-month recruitment period remains the operational basis.
The validated clinical database and randomisation system, electronic case-report forms, pharmacovigilance processes, risk-based monitoring and medical-imaging transfer workflow became operational. The patient app and Digital Health Intervention Platform were developed and tested. A decentralised biobank was implemented under harmonised procedures; baseline biosamples from all 72 randomised participants were collected and stored locally at -80 degrees Celsius pending later central transfer.
The consortium also completed a Health Economics Statistical Analysis Plan and a country-adaptable microsimulation model covering costs, healthcare use, quality-adjusted life years and disability-adjusted life years. A Data Management Plan and initial FAIR-data framework were established, and a structured consultation with clinical, patient and professional stakeholders generated recommendations for trial implementation and future evidence uptake. The first peer-reviewed open-access SGLT2-HYPE article, describing the scientific rationale and trial design, was published in the European Heart Journal in May 2026.
