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Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.
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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
| University Hospital Olomouc | OTHER |
| Cardiocenter PodlesÃ, Trinec, Czech Republic | UNKNOWN |
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Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation | Experimental | Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization) |
|
| Medical treatment | No Intervention | Conventional antihypertensive treatment including spironolactone (if not contraindicated). One year after randomization, renal denervation can be performed according to the physician's decision based on the BP levels and if patient desires the procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal denervation (Symplicity® Catheter System™) | Device | 4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure difference | Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure differences similar to primary outcome | Systolic and Diastolic BP differences (comparison between baseline and evaluated time period) will be measured using 24-hours monitoring and also at office. | 1 year, 2 years, 3 years |
| Change of blood laboratory parameters and renal function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petr Widimsky, Prof, MD | Charles University, Prague, Czech Republic | Principal Investigator |
| Jiri Widimsky, Prof.MD. | General University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiocenter, University Hospital Olomouc | Olomouc | Czechia | ||||
| Jiri Widimsky |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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changes in blood concentrations of renin, aldosterone, metanephrines and renal function |
| 6 months, 1, 2, 3 years |
| Post-denervation renal anatomy assessment | CT angiography will be performed 1 year after RDN | 1 year |
| Prague |
| Czechia |
| Cardiocenter Podlesi | Třinec | Czechia |