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Study of Dapagliflozin for Reducing Cardiovascular Events in Adults with High Blood Pressure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Arterial Hypertension, a condition where blood pressure is higher than normal. The study will test whether adding a medication called Dapagliflozin, which belongs to a group of drugs known as SGLT2 inhibitors, to standard blood pressure treatment can help reduce heart and kidney problems in patients with high blood pressure.

The study will use Dapagliflozin film-coated tablets containing 10 milligrams of the medication, which will be taken by mouth once daily. Some participants will receive the active medication, while others will receive a placebo. The treatment period will last for 78 weeks, during which the effects of the medication on heart health and kidney function will be monitored.

The main purpose of this research is to determine if adding this medication to regular blood pressure treatment can lower the risk of serious heart-related events, such as heart attacks, strokes, and kidney problems. The study will also look at how well the medication controls blood pressure and its effects on overall health and quality of life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your blood pressure will be measured to confirm it meets the study criteria (≥140/90 mmHg)

    Your medical history will be reviewed, particularly focusing on heart and blood vessel conditions

    Basic health measurements will be taken, including height, weight, and kidney function tests

  2. Step 2

    Medication assignment

    You will receive either dapagliflozin (10 mg tablet) or a placebo tablet

    The medication should be taken by mouth once daily

    You will continue taking your regular blood pressure medications

  3. Step 3

    8-week follow-up

    Your blood pressure will be checked

    Kidney function tests will be performed

    Any side effects will be recorded

  4. Step 4

    12-month evaluation

    Blood pressure measurement

    Quality of life assessment

    Memory and thinking ability test

    Blood samples for specific testing

    Physical capability assessment

  5. Step 5

    24-month evaluation

    Repeat of quality of life assessment

    Memory and thinking ability test

    Blood samples collection

    Physical capability check

  6. Step 6

    48-month final evaluation

    Final blood pressure measurement

    Final kidney function assessment

    Final quality of life assessment

    Final memory and thinking ability test

    Final blood samples collection

    Final physical capability assessment

Who can join the trial?

16 criteria

  • Must be 60 years of age or older
  • Must have either:
    • High blood pressure readings showing systolic pressure of 140 or higher or diastolic pressure of 90 or higher measured twice on different days if newly diagnosed, or
    • One measurement showing these values if already diagnosed with high blood pressure
    • Must have experienced at least one of these heart or blood vessel problems:
      • Heart attack (but not in the past 3 months)
      • Stroke (but not in the past 3 months)
      • Stable chest pain
      • Known heart disease
      • Blood vessel disease in limbs
      • Mini-stroke (transient ischemic attack)
      • OR must have at least one of these risk factors:
        • Current smoker (more than one cigarette daily for at least 1 year)
        • High cholesterol (LDL level of 4.0 or higher)
        • Age 75 or older
        • High heart risk score (ESC HeartScore of 15% or higher)
        • Body Mass Index of 32 or higher
        • Reduced kidney function (eGFR of 60 or lower)
        • Can be either male or female

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Currently participating in other clinical trials
  • Known allergy or hypersensitivity to SGLT2 inhibitors (medications that help lower blood sugar)
  • History of severe allergic reactions to any medications
  • Pregnant or breastfeeding women
  • Severe kidney disease or requiring dialysis
  • History of diabetic ketoacidosis (a serious complication where the body produces high levels of blood acids)
  • Uncontrolled diabetes mellitus (consistently high blood sugar levels)
  • History of severe heart problems in the past 6 months
  • Active liver disease or significant liver function abnormalities
  • History of frequent urinary tract infections
  • Low blood pressure or history of frequent episodes of low blood pressure
  • Unable to provide informed consent
  • Mental conditions that may interfere with study compliance
  • Life expectancy less than 12 months due to other medical conditions
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Investigated drugs

  • SGLT2 inhibitor

    is a type of medication that helps lower blood sugar levels by preventing the kidneys from reabsorbing glucose back into the blood. In this trial, it is being studied as an additional treatment alongside standard blood pressure medications. SGLT2 inhibitors may help protect the heart and kidneys while also helping to control blood pressure.

  • Standard antihypertensive medications

    are conventional medications used to treat high blood pressure. These medications work in different ways to help lower blood pressure and protect against heart-related complications. They form the baseline treatment in this study, with the SGLT2 inhibitor being added to evaluate additional benefits.

What is already known about the treatment

SGLT2 inhibitors - A class of oral medications used to treat high blood pressure and protect heart and kidney function. These drugs work by blocking sodium-glucose co-transporters in the kidneys, which leads to increased glucose excretion in urine and reduces blood pressure through osmotic diuresis. Currently well-established in medical practice, SGLT2 inhibitors are considered an important therapeutic option for patients with arterial hypertension, especially those with concurrent cardiovascular risks or diabetes. The medication represents a novel approach to blood pressure management by targeting both glucose metabolism and blood pressure regulation mechanisms through a single therapeutic intervention. Note: Since the trial data doesn't specify a particular SGLT2 inhibitor medication by trade name, I've provided a description of the class of medications being studied in the trial.

Investigated diseases

  • Arterial Hypertension

    A chronic cardiovascular condition where blood pressure in the arteries is persistently elevated above normal levels. The condition develops when the force of blood pushing against the walls of blood vessels remains consistently high. Blood pressure is measured using two numbers: systolic pressure (when the heart beats) and diastolic pressure (when the heart rests between beats). Hypertension can gradually damage blood vessels and organs over time if not properly managed. The condition often develops slowly over many years and may exist without noticeable symptoms.

  • Heart Failure

    A condition where the heart cannot pump blood effectively enough to meet the body's needs. The heart continues to work but becomes less efficient at delivering oxygen and nutrients throughout the body. This can cause fluid to build up in various parts of the body, particularly the lungs, ankles, and feet. The condition can develop gradually over time as the heart becomes weaker or less able to fill properly.

  • Atrial Fibrillation

    An irregular heart rhythm condition where the upper chambers of the heart beat chaotically and out of coordination with the lower chambers. This irregular heartbeat can cause poor blood flow through the heart. The condition can be occasional, persistent, or permanent, and often causes the heart to beat faster than normal.

  • Type 2 Diabetes

    A metabolic disorder that affects how the body processes glucose (blood sugar). In this condition, the body either doesn't produce enough insulin or becomes resistant to insulin's effects. The condition typically develops gradually, and blood sugar levels rise slowly over time. Early stages may not show obvious symptoms.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520794-39-00Protocol code724154Estimated enrolment3 590 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

sourced from the EU Clinical Trials Register and site verification

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