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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Regionshospitalet Silkeborg | OTHER |
| Randers Regional Hospital | OTHER |
| Central Jutland Regional Hospital |
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The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation by ablation of the renal arteries | Active Comparator | By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to active treatment, renal artery ablation will be carried out straight away. |
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| Control | Sham Comparator | By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to sham treatment, the procedure stops. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation of the renal arteries | Procedure | Catheter-based renal denervation by applying low power radiofrequency to the renal artery using the EnligHTN Catheter, introduced by femoral artery access. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in blood pressure (clinic and 24-hour ambulatory blood pressure measurement) | 3 and 6 months | |
| Change from baseline in central blood pressure, augmentation index and pulse wave velocity | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Vase, MD, PhD | Skejby Hospital, Dept. of Cardiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Skejby | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Regional Hospital Holstebro | OTHER |
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| Renal angiography | Procedure | Renal angiography by femoral access |
|
| Change from baseline in cold pressor response | 6 months |
| Change from baseline in intensity of medical antihypertensive therapy | 1, 3 and 6 months |
| Blood pressure (clinic measurement) | 1, 3 and 6 months |
| Renal function (eGFR and electrolytes) | 1, 3 and 6 months |