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Background: In hypertension, a highly prevalent disease, up to 10-15% of hypertensive patients have uncontrolled blood pressure despite a regimen of â„ 3 drugs, which is known as resistant hypertension (RH). Cardiovascular prognosis in patients with RH is worse than in controlled hypertensives. Efferent renal sympathetic nerves play an important role in volume homeostasis and blood pressure. A novel minimally invasive technique based on the use of selective radiofrequency renal sympathetic denervation has shown promising preliminary results for the treatment of these patients. On the other hand, some patients with RH could improve their blood pressure control by adding spironolactone, an antagonist of aldosterone receptors.
Objective: To evaluate the efficacy of radiofrequency renal sympathetic denervation in patients with RH, as compared with the addition of spironolactone to the therapeutic regimen at baseline.
Method: interventional, prospective, randomized, open study, of a cohort of 50 patients with RH, with office systolic blood pressure â„ 150 mmHg and also with 24h systolic blood pressure â„ 140 mmHg, despite treatment with â„ 3 drugs in adequate doses, one of them a diuretic, and whitout treatment with either spironolactone or eplerenone. Patients will be randomized (1:1) to renal sympathetic denervation treatment or spironolactone (50mg), performing determination of office blood pressure and 24h-ABPM at pre-randomization, 1, 3 and 6 months, as well as laboratory tests, echocardiography, measurement of carotid intima-media thickness and central blood pressure measurement at pre-randomization and after 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Denervation |
|
| B | Active Comparator | Treatment with aldactone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sympathetic Renal Denervation | Procedure |
| ||
| Treatment with aldactone |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ambulatory 24h-systolic blood pressure (SBP). | From baseline (Visit 0) to Final Examination (6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ambulatory 24h-diastolic blood pressure (DBP), pulse pressure (PP) and heart rate (HR) | From baseline (Visit 0) to Final Examination (6 months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | Barcelona | 08003 | Spain | ||
| Hospital General de l'Hospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29316186 | Derived | Oliveras A, Armario P, Sans L, Clara A, Vazquez S, Molina L, Pareja J, de la Sierra A, Pascual J. Organ damage changes in patients with resistant hypertension randomized to renal denervation or spironolactone: The DENERVHTA (Denervacion en Hipertension Arterial) study. J Clin Hypertens (Greenwich). 2018 Jan;20(1):69-75. doi: 10.1111/jch.13156. Epub 2018 Jan 5. | |
| 27327441 |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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|
| Hospitalet |
| Barcelona |
| 08906 |
| Spain |
| Hospital Universitari MĂștua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Oliveras A, Armario P, Clara A, Sans-Atxer L, Vazquez S, Pascual J, De la Sierra A. Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study - a randomized controlled trial. J Hypertens. 2016 Sep;34(9):1863-71. doi: 10.1097/HJH.0000000000001025. |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |