Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Sympathetic Renal Denervation Versus Increment of Pharmacological Treatment in Resistant Arterial Hypertension
Brief Summary: Background: In hypertension, a highly prevalent disease, up to 10-15% of hypertensive patients have uncontrolled blood pressure despite a regimen of ≥ 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 ≥ 150 mmHg and also with 24h systolic blood pressure ≥ 140 mmHg, despite treatment with ≥ 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.


Options:
A: Arm Label: Investigational Therapy (Surround Sound); Type: EXPERIMENTAL; Interventions: Device: Investigational Therapy (Surround Sound) | Arm Label: Sham Control; Type: SHAM_COMPARATOR; Interventions: Device: Sham Control | Intervention Type: DEVICE; Name: Investigational Therapy (Surround Sound); Assigned to Arm(s): Investigational Therapy (Surround Sound) | Intervention Type: DEVICE; Name: Sham Control; Assigned to Arm(s): Sham Control
B: Arm Label: group Co; Type: ACTIVE_COMPARATOR; Interventions: Device: The HOTMAN® System | Arm Label: group RDN; Type: ACTIVE_COMPARATOR; Interventions: Procedure: The SymplicityTM Renal Denervation System | Intervention Type: PROCEDURE; Name: The SymplicityTM Renal Denervation System; Assigned to Arm(s): group RDN | Intervention Type: DEVICE; Name: The HOTMAN® System; Assigned to Arm(s): group Co
C: Arm Label: A; Type: EXPERIMENTAL; Interventions: Procedure: Sympathetic Renal Denervation | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Treatment with aldactone | Intervention Type: PROCEDURE; Name: Sympathetic Renal Denervation; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Treatment with aldactone; Assigned to Arm(s): B
D: Arm Label: Renal sympathetic denervation; Type: EXPERIMENTAL; Interventions: Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA) | Arm Label: Sham procedure; Type: SHAM_COMPARATOR; Interventions: Other: Sham procedure | Intervention Type: DEVICE; Name: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA); Assigned to Arm(s): Renal sympathetic denervation | Intervention Type: OTHER; Name: Sham procedure; Assigned to Arm(s): Sham procedure

Answer: C