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

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What is this study about?

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.

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 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 8-week follow-up

Your blood pressure will be checked

Kidney function tests will be performed

Any side effects will be recorded

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 24-month evaluation

Repeat of quality of life assessment

Memory and thinking ability test

Blood samples collection

Physical capability check

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Coburg GmbH Coburg Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Stiftung Bremer Herzen Bremen Germany
University Medical Center Ljubljana Ljubljana Slovenia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Herz-Kreislauf-Klinik Bevensen AG Bad Bevensen Germany
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz Madrid Spain
Ughxypuhwwalisrmkprxu Emlvk Awd Essen Germany
Sjzmurzkhr Kesxsrks Bad Segeberg Germany
Uofepiziif Hvbhpypa Cxejgos Cologne Germany
Aekfpqd Ohnrsasaldc Uumxfuupihhhe Oekshtpk Rfxnpgi Foggia Italy
Aqykivp Udphs Sykipgxgf Lqqqkg Dn Bihozza Bologna Italy
Kukbmwfd Woorirwgluploaey Gxbb Ahaus Germany
Hwawcu Pnxmfocqajqfn Lopesqr Gvgk Leipzig Germany
Glmeqj Uqdywjtxfs Fgfauzqks Frankfurt Germany
Ukbpobzfhkehihkhkcnzf Dqbrslrgbuh Atb Duesseldorf Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.12.2025
Germany Germany
Recruiting
01.12.2025
Italy Italy
Not yet recruiting
01.12.2025
Portugal Portugal
Not yet recruiting
01.12.2025
Slovenia Slovenia
Recruiting
01.12.2025
Spain Spain
Not yet recruiting
01.12.2025

Trial locations

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.

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 ID:
2025-520794-39-00
Protocol code:
724154
NCT ID:
NCT06804161
Trial Phase:
Therapeutic confirmatory (Phase III)

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