For Clinicians
The SGLT2 HYPE trial is a large, international, multicentre, randomized, double-blind, placebo-controlled study evaluating whether the SGLT2 inhibitor dapagliflozin reduces cardiovascular and renal events in older adults with uncontrolled hypertension.
Clinical Trials.gov Number:
NCT0680416
If you would like to learn more about the study plan and participation criteria click here.
Key Clinical Rationale
- Despite current antihypertensive treatments, residual cardiovascular risk remains high in patients with long-standing hypertension, partly due to end-organ damage that is insufficiently addressed.
- SGLT2 inhibitors have demonstrated blood pressure-lowering effects and pleiotropic organ protection in heart failure and chronic kidney disease, sequela of hypertension – even in non-diabetic patients.
- However, they are not currently approved for primary hypertension. This trial aims to close this evidence gap and inform future guidelines.
Key Inclusion Criteria
- Age ≥ 60 years
- Elevated blood pressure (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg)
- Either:
- A history of cardiovascular disease (myocardial infarction* or stroke*; stable angina or clinical evidence of coronary heart disease; peripheral arterial disease; transient ischemic attack)
- Or presence of CV risk factors, such as:
- Active smoking
- LDL-C > 4.0 mmol/L
- Age ≥ 75 years
- ESC Heart Score >15%
- BMI > 32 kg/m²
- eGFR < 60 mL/min/1.73m²
*Note: Recent (<3 months) MI or stroke are exclusion criteria.
Key Exclusion Criteria
- Known secondary cause of hypertension
- Myocardial infarction or stroke within the previous 3 months
- Symptomatic heart failure
- History of Diabetes mellitus
- History of ketoacidosis
- eGFR <25 mL/min/1.73 m2 (CKD-EPICr 2021 formula) at Visit 1
- Receiving therapy with an SGLT2i within 8 weeks prior to randomization or previous intolerance to an SGLT2i
- Participation in another clinical study with an investigational product during the last month prior to enrolment
- Known allergy or hypersensitivity to SGLT2i
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Any medical condition – outside the renal and CV disease area – with a life expectancy of less than 2 years based on investigator’s clinical judgement
- Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)
Study Design
- Population: > 3,000 participants in Europe
- Intervention: Dapagliflozin 10 mg vs. placebo
- Primary endpoint: Composite of CV and renal morbidity and mortality
- Secondary endpoints: Blood pressure control, quality of life (EQ-5D), safety
- Follow-up: Minimum of 4 years
How to refer a patient
If you would like to refer a potentially eligible patient, please complete the contact form below. A member of the research team will follow up with you promptly to provide further information and next steps.
Find out more here
New EU-funded Project Aims to Transform Hypertension Treatment
SGLT2 HYPE is a guideline-relevant clinical trial aiming to establish SGLT2 inhibitors as a new standard in high blood pressure therapy, ultimately addressing one of the leading causes of premature mortality in Europe