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Sympathetic Renal Denervation Versus Increment of Pharmacological Treatment in Resistant Arterial Hypertension.

NCT02039492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-09-29

No results posted yet for this study

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.

Conditions

  • Resistant Arterial Hypertension

Interventions

PROCEDURE

Sympathetic Renal Denervation

DRUG

Treatment with aldactone

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039492 on ClinicalTrials.gov