Atrial HypertensionPhase 3SGLT2-HYPENCT06804161
SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension
A Phase 3 study testing SGLT2 in people with Atrial Hypertension, run by Prof. Dr. med. Ingo Eitel at 1 site in Germany.
Trial summary
Hypertension (HTN) is a leading cause of cardiovascular disease (CVD). Despite existing therapies, patients with HTN still face substantial risks, due to pre-existing and ongoing end-organ damage due, in part, to inadequate blood pressure (BP) control. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Atrial Hypertension
- What is being tested?
- SGLT2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 10 Dec 2025to 30 May 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60 years
- 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.
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elias Rawish, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Universität zu Lübeck
Lübeck, Schleswig-Holstein, 23538
Ingo Eitel, Prof. Dr. med.
Thomas Stiermaier, Dr.med
About this study
Hypertension (HTN) is a leading cause of cardiovascular disease (CVD). Despite existing therapies, patients with HTN still face substantial risks, due to pre-existing and ongoing end-organ damage due, in part, to inadequate blood pressure (BP) control. SGLT2 inhibitors (SGLT2i) are recommended for both type-2 diabetes and heart failure to reduce morbidity and mortality. SGLT2i reduce BP and might also improve outcomes for HTN by reducing end-organ damage through diverse other actions. However, confirmation that SGLT2i are clinically useful for the management of HTN is required to change guidelines and clinical practice.
- Conditions
- Atrial Hypertension
- Being tested
- SGLT2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2Drug
10 mg
PlaceboDrug
1 tablet
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 Arm | Experimental | Not described Receives: Drug: SGLT2 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until first occurrence of
Measured: 7 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start10 Dec 2025
- Primary completion30 May 2032 (estimated)
- Study completion30 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Ingo Eitel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Ingo Eitel, University of Luebeck
- Investigators
- Ingo Eitel, Prof. Dr., Principal investigator, Universitätsklinikum Schleswig-Holstein - Campus Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804161
- Sponsor's protocol ID
- 724154
- Acronym
- SGLT2-HYPE
- Status last verified
- Dec 2025
- First submitted
- 27 Jan 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension
- ClinicalTrials.gov ID
- NCT06804161
- Acronym / sponsor ID
- SGLT2-HYPE / 724154
- Conditions
- Atrial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Ingo EitelUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 30 May 2032 (estimated)
- Study completion
- 30 May 2032 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertension (HTN) is a leading cause of cardiovascular disease (CVD). Despite existing therapies, patients with HTN still face substantial risks, due to pre-existing and ongoing end-organ damage due, in part, to inadequate blood pressure (BP) control. SGLT2 inhibitors (SGLT2i) are recommended for both type-2 diabetes and heart failure to reduce morbidity and mortality. SGLT2i reduce BP and might also improve outcomes for HTN by reducing end-organ damage through diverse other actions. However, confirmation that SGLT2i are clinically useful for the management of HTN is required to change guidelines and clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2 Arm | Experimental | Drug: SGLT2 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥60 years
- 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.
- 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)
Key exclusion criteria (13 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT210 mg | Drug | SGLT2 Arm |
| Placebo1 tablet | Drug | Placebo |
Primary outcome
Time until first occurrence of
Time frame: 7 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elias Rawish, Dr. contact
Ingo Eitel, Prof. Dr. principal investigator
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SGLT2 in people with Atrial Hypertension, run by Prof. Dr. med. Ingo Eitel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingo Eitel, Prof. Dr. (045150044542, cvro@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until first occurrence of (time frame: 7 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.