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

NCT02039492 | Completed

• 1 other identifier: DENERVHTA
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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.

Conditions

Resistant Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in ambulatory 24h-systolic blood pressure (SBP).

  From baseline (Visit 0) to Final Examination (6 months).

Secondary Outcomes (1)

• Changes in ambulatory 24h-diastolic blood pressure (DBP), pulse pressure (PP) and heart rate (HR)

  From baseline (Visit 0) to Final Examination (6 months).

Study Arms (2)

A

EXPERIMENTAL

Denervation

Procedure: Sympathetic Renal Denervation

B

ACTIVE COMPARATOR

Treatment with aldactone

Drug: Treatment with aldactone

Interventions

Sympathetic Renal Denervation PROCEDURE

A

Treatment with aldactone DRUG

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥ 18 years and ≤ 80 years.
• Subjects with diagnosed resistant arterial hypertension (office blood pressure ≥ 140 and/or 90 mm Hg despite treatment with at least 3 antihypertensive drugs given at the maximum tolerated therapeutic dosage, being one of them a diuretic), with this therapeutic regimen maintained for at least the last 3 months.
• Office systolic blood pressure ≥150 mm Hg, with confirmation of resistance to treatment by 24h ambulatory blood pressure monitoring, with 24h-systolic blood pressure ≥140 mmHg being required to be included.
• Patients who have freely given informed consent in writing, after the nature of the study and the disclosure of their data have been explained to them.

You may not qualify if:

• \. Secondary hypertension, renovascular disease included with appropriate tests according to investigator criteria (with the exceptions of chronic renal disease and obstructive sleep-apnea syndrome). 2. Inability to perform magnetic resonance angiography or renal CT angiography (contrast allergy). 3. Patients unlikely compliant with treatment (assessed according to Haynes-Sackett test). 4. Patients currently on treatment with an aldosterone receptor blocker (spironolactone, eplerenone) or who had previously received one of such class of drugs and had been withdrawn due to lack of efficacy and/or adverse effects. 5. Stage 3B, 4 or 5 of chronic renal disease (estimated glomerular filtration rate by MDRD equation \< 45 mL/min/1.73m2). 6. Pre-randomization serum potassium (K+) level ≥ 5.5 mmol/L. 7. Significant renal vascular anomalies. 8. Pregnant women. 9. Significant valvular heart disease. 10. Major vascular event (myocardial infarction, unstable angina or cerebrovascular disease) \< 6 months prior to study enrolment.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (3)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital General de l'Hospitalet

Hospitalet, Barcelona, 08906, Spain

Location

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Related Publications (2)

• 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.

  PMID: 29316186 DERIVED

• 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.

  PMID: 27327441 DERIVED

MeSH Terms

Interventions

Therapeutics; Spironolactone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 17, 2014
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

ES (3)