SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SGLT2, Placebo.
- Who it may be relevant to
- Registry conditions: Atrial Hypertension. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug SGLT2
10 mg - Drug Placebo
1 tablet
Primary outcome measures
- Time until first occurrence of [Time frame: 7 Years]
Eligibility criteria
Inclusion criteria
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Universität zu Lübeck — Lübeck
Identifiers
NCT: NCT06804161 · 724154