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NotablePrimary endpoints: details revised at 1 of 1 entryTrial sites expanded: 953 → 957 locations · Eligibility criteria shortened, about 7 words · Secondary endpoints: details revised at 5 of 5 entries · 1 moreShow 4 more changesShow less
Trial sites expanded: 953 → 957 locations
Eligibility criteria shortened, about 7 words
Secondary endpoints: details revised at 5 of 5 entries
Publications: details revised at 1 of 1 entry
MinorTrial sites expanded: 942 → 953 locationsv16
MinorTrial sites expanded: 928 → 942 locationsv15
MinorTrial sites expanded: 917 → 928 locationsv14
MinorStudy sites: 916 to 917v13
Show 11 earlier versionsHide 11 earlier versions
MinorStudy sites: 918 to 916Eligibility criteria shortened, about 210 words · Secondary endpoints: 7 to 5v12Show 2 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 581 to 769 · Start date changed from estimate of Mar 28, 2025 to Mar 14, 2025v3Show 2 more changesShow less
Study sites: 581 to 769
Start date changed from estimate of Mar 28, 2025 to Mar 14, 2025
MinorStudy sites: 95 to 581Eligibility criteria expanded, about 53 wordsv2Show 1 more changeShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF.
The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1.
Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation.
Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months.
The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD.
In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.