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Could a common diabetes drug slash heart risks in hypertension?

NCT ID NCT06804161

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a daily SGLT2 inhibitor pill can reduce heart attacks, strokes, and other cardiovascular events in 3,000 adults aged 60+ with high blood pressure and a history of heart or blood vessel problems. Participants will receive either the drug or a placebo for several years. The goal is to see if this drug, already used for diabetes and heart failure, can offer extra protection for people with hypertension.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SGLT2 inhibitor (a type of diabetes drug that also lowers blood pressure)
What this could lead to
If successful, this could lead to a new standard treatment to prevent heart attacks and strokes in people with high blood pressure.
What could go wrong
This is a large phase 3 trial, but SGLT2 inhibitors are already used for diabetes and heart failure, so the added benefit for hypertension alone may be modest. Side effects like dehydration or infections are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥60 years 2. Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg in two measurements on different days for newly diagnosed hypertension, or through one measurement at the screening visit for patients with an existing diagnosis of hypertension. 3. A history of at least one CV event (myocardial infarction\* or stroke\*; stable angina or clinical evidence of coronary heart disease; peripheral arterial disease; transient ischemic attack) or The presence of at least one cardiovascular risk factor (current smoking of more than one cigarette per day during at least 1 year; LDL-cholesterol \> 4,0 mmol/l, Age ≥ 75 years, ESC HeartScore \> 15%, BMI \> 32 kg/m2) \*excluding patients with myocardial infarction or stroke within preceding 3 months Exclusion Criteria:- Known secondary cause of hypertension * Myocardial infarction or stroke within the previous 3 months * Symptomatic heart failure (including HFrEF, HFmEF, HFpEF) * History of Diabetes mellitus * History of ketoacidosis * Hepatic impairment (aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \>3x the upper limit of normal \[ULN\]) * 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) * Inability to give informed consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universität zu Lübeck

    RECRUITING

    Lübeck, Schleswig-Holstein, 23538, Germany

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