Atrial Hypertension
Conditions
Brief 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. 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
DRUGSGLT2
10 mg
DRUGPlacebo
1 tablet
Sponsors
Prof. Dr. med. Ingo Eitel
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time until first occurrence of | 7 Years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoints | 7 Years | * AE (general) * AE leading to treatment discontinuation * SAE * AE of special interest (AESI): including volume depletion, hypotension, metabolic acidosis and ketoacidosis |
Countries
Germany
Contacts
Primary ContactIngo Eitel, Prof. Dr.
Backup ContactElias Rawish, Dr.
Outcome results
None listed