I10.90
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Uncontrolled arterial hypertension with a clinical indication for renal denervation Optional: MRI compatibility (no tinnitus, no tattoos, no magnetic implants)
Exclusion criteria
Exclusion criteria: 1. Clinically significant and uncontrolled supraventricular or ventricular cardiac arrhythmias (excluding adequately rate-controlled atrial fibrillation) 2. Severe valvular heart disease and/or valvular disease requiring intervention 3. History of significant neurological or psychiatric disorders (e.g., seizure disorders, severe traumatic brain injury, depression, schizophrenia, dementia) 4. Malignancies limiting life expectancy 5. Intolerance to ASA (acetylsalicylic acid) 6. Impaired renal function (GFR <40 ml/min/1.73 m²) 7. Renal artery stenosis 8. Untreated secondary causes of hypertension 9. Severe aortic atherosclerosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Impact of renal denervation on microvascular function (retinal vascular function, PWV, FMD; pre and post) •Temporal dynamics of the effects of renal denervation on home blood pressure (remote telemonitoring over 12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Cardiovascular fitness (VO2max, grip strength, muscle mass) • Cardiovascular risk profile (composite score: blood pressure, lipid levels, physical activity, obesity) • Clinical parameters for vascular function (e.g. arterial stiffness) • Clinical parameters for cardiac function (e.g., LVEF, diastolic function) • Microvascular function (MRI: STRIVE score) • Cognition (composite cognition score) • Blood parameters (inflammation, BDNF, Klotho, dementia markers, etc.) • Lifestyle factors • Frequency/severity of AEs and SAEs | — |
Countries
Germany
Contacts
Uniklinik Magdeburg