Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter-based renal denervation | Experimental | One procedure will be performed using one of the CE-marked devices for renal denervation: Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix |
|
| Medical therapy | No Intervention | Best medical therapy using guideline recommended drugs in each disease state. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal denervation with Symplicity Flex Medtronic/Ardian | Device | Renal denervation using CE-marked devices will be performed according to best medical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy of renal denervation | Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of renal denervation on different organ systems. | Myocardial function and geometry using echo and MRI. Heart rate changes and arrhythmias. Glucose metabolism and insulin resistance (fasting and during oGTT). Hospitalization rates (eg. hypertensive emergencies, heart failure, etc). | Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felix Mahfoud, MD | Contact | +4968411621346 | felix.mahfoud@uks.eu | |
| Michael Böhm, MD | Contact | +4968411623372 | michael.boehm@uks.eu |
| Name | Affiliation | Role |
|---|---|---|
| Felix Mahfoud, MD | University Hospital, Saarland | Study Director |
| Michael Böhm, MD | University Hospital, Saarland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Saarland | Recruiting | Homburg/Saar | 66421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38572643 | Derived | Lauder L, Siwy J, Mavrogeorgis E, Keller F, Kunz M, Wachter A, Emrich IE, Bohm M, Mischak H, Mahfoud F. Impact of Renal Denervation on Urinary Peptide-Based Biomarkers in Hypertension. Hypertension. 2024 Jun;81(6):1374-1382. doi: 10.1161/HYPERTENSIONAHA.124.22819. Epub 2024 Apr 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Renal denervation with EnligHTN St. Jude Medical | Device | Renal denervation using CE-marked devices will be performed according to best medical practice. |
|
| Renal denervation with Paradise Recor | Device | Renal denervation using CE-marked devices will be performed according to best medical practice. |
|
| Renal denervation with V2 Vessix | Device | Renal denervation using CE-marked devices will be performed according to best medical practice. |
|
| Safety and efficacy of renal denervation | Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound. | Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006333 | Heart Failure |
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided