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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Medtronic | INDUSTRY |
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The aim of this study is to assess whether renal denervation (RD) added to usual care compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least 135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) obstructing use of 3 antihypertensives
Further aims are to assess the effect of renal denervation on the use of BP lowering agents, to explore the effect of renal denervation in strata of estimated glomerular filtration rate (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR>60 mL/min per 1.73m2) and according to baseline office BP.
Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal sympathetic denervation | Experimental | Catheter-based renal nerve ablation |
|
| Usual care | No Intervention | Antihypertensive treatment according to guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal sympathetic denervation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BP (measured by ABPM) | Change in BP: average day-time systolic blood pressure (SBP) as determined with the use of ambulatory blood pressure-monitoring at 6 months and during prolonged follow up (total 2 years) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the amount of antihypertensive medication | Change in antihypertensive medication defined as daily defined dose (DDD) of all prescribed drugs after 6 months and during prolonged follow up (total: 2 years) | 6 months |
| Change in BP in eGFR strata |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on quality of life | Impact on quality of life of RD will be measured with Short-Form 36 and EuroQol-5 Dimensions (EQ-5D) measurement instruments. Assessments at 6 months and during prolonged follow up (total 2 years) | 6 months |
| Cost-effectiveness |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Utrecht | Utrecht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28264922 | Derived | de Jager RL, de Beus E, Beeftink MM, Sanders MF, Vonken EJ, Voskuil M, van Maarseveen EM, Bots ML, Blankestijn PJ; SYMPATHY Investigators. Impact of Medication Adherence on the Effect of Renal Denervation: The SYMPATHY Trial. Hypertension. 2017 Apr;69(4):678-684. doi: 10.1161/HYPERTENSIONAHA.116.08818. | |
| 24576513 | Derived |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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The effect on BP of RD in strata of eGFR: eGFR 20-60 mL/min per 1.73m2 versus eGFR>60 mL/min per 1.73m2 at 6 months after intervention and during prolonged follow up (total 2 years) |
| 6 months |
| Change in office BP | Change in office blood pressure at 6 months after intervention and during follow up (total 2 years) | 6 months |
Cost-effectiveness of RD will be calculated. For this purpose, health care and indirect costs will be monitored with use of data from the case report form and questionnaires. Absence from work will be assessed using parts of the Short-Form Health and Labour Questionnaire. Assessments at 6 months and during prolonged follow up (total 2 years)
| 6 months |
| Vink EE, de Beus E, de Jager RL, Voskuil M, Spiering W, Vonken EJ, de Wit GA, Roes KC, Bots ML, Blankestijn PJ. The effect of renal denervation added to standard pharmacologic treatment versus standard pharmacologic treatment alone in patients with resistant hypertension: rationale and design of the SYMPATHY trial. Am Heart J. 2014 Mar;167(3):308-314.e3. doi: 10.1016/j.ahj.2013.11.010. Epub 2013 Dec 4. |
| 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 |