/A

Conditions: subjects with resistant hypertension
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2012-001066-14-ES

Lead Sponsor: Consorci Mar Parc de salut de Barcelona ( Parc de Salut Mar)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Subjects aged = 18 years and = 80 years.

2.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.

3.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.

4.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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.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receptor blocker (spironolactone, eplerenone) or who had previously received one of such class of drugs and had been withdrawn due to lack of efficacy and/or adverse effects.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.