Resistant Arterial Hypertension Clinical Trial
Official title:
Sympathetic Renal Denervation Versus Increment of Pharmacological Treatment in Resistant Arterial Hypertension
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy
|
N/A | |
| Completed |
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Systemic Microvascular Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation
|