subjects with resistant hypertension
Conditions
Interventions
Trade Name: Aldactone
Product Name: SPIRONOLACTONE
Pharmaceutical Form: Coated tablet
INN or Proposed INN: spironolactone
CAS Number: 52-01-7
Concentration unit: mg milligram(s)
Concentration type: r
Sponsors
Consorci Mar Parc de salut de Barcelona ( Parc de Salut Mar)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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receptor blocker (spironolactone, eplerenone) or who had previously received one of such class of drugs and had been withdrawn due to lack of efficacy and/or adverse effects. 5.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: related in secction E.5.1;Main Objective: To determine the effect of a percutaneous catheter-based renal sympathetic denervation (RSD) procedure to disrupt renal afferent and efferent nerves using radiofrequency ablation, on 24h ambulatory systolic blood pressure (SBP), in subjects with resistant hypertension (RH), as compared to the addition of spironolactone, an aldosterone receptor blocker, to the baseline pharmacological treatment, from baseline (Visit 0) to Final Examination (Week 24). ;Secondary Objective: To determine the effect of the RSD procedure by radiofrequency ablation in subjects with resistant hypertension (RH), as compared to the addition of spironolactone, an aldosterone receptor blocker, to the baseline pharmacological treatment, from baseline (Visit 0) to Final Examination (Week 24), with respect to: Office Blood Pressure (BP),24 h-ambulatory BP, central BP, pulse pressure, and carotid-femoral pulse wave velocity, carotid intima-media thickness, and echocardiographic parameters;Primary end point(s): Change in ambulatory 24h-systolic blood pressure (SBP) from baseline (Visit 0) to Final Examination (6 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in ambulatory 24h-diastolic blood pressure (DBP), pulse pressure (PP) and heart rate (HR) from baseline (Visit 0) to Final Examination (6 months). • Changes in day-time SBP, DBP, PP and HR measurement from baseline (Week 0) to Final Examination (6 months). • Changes in night-time SBP, DBP, PP and HR measurement from baseline (Week 0) to Final Examination (6 months). • Changes in conventional mean sitting SBP, DBP, PP and HR measurement from baseline (Week 0) to Final Examination (6 months). • Changes in central SBP, DBP, PP and HR measurement from baseline (Week 0) to Final Examination (6 months). • Changes in central augmentation index and central augmentation pressure from baseline (Week 0) to Final Examination (6 months). • Changes in carotid-femoral pulse wave velocity from baseline (Week 0) to Final Examination (6 months). • Changes in evaluated echocardiographic parameters (left ventricular mass index [LVMI], left atrial enlargement [LAE], ejection fraction [EF], left ventricular remodeling index [LVRI], E/e’, Global function index (E/e´)/s; left atrial parameters: area 4c, area index, volume, strain register; 2D LV strain parameters: longitudinal strain and radial strain) from baseline (Week 0) to Final Examination (6 months). • Changes in evaluated renal function parameters (urinary albumin/creatinine ratio, serum creatinine, estimated glomerular filtration rate) and evaluated metabolic parameters (glucemia, lipidic profile) from baseline (Week 0) to Final Examination (6 months). • Changes in carotid intima-media thickness measurement from baseline (Week 0) to Final Examination (6 months). ;Timepoint(s) of evaluation of this end point: related in secction E.5.2 | — |
Countries
Spain
Contacts
Public ContactServicio de Nefrologia
Hospital del Mar
Outcome results
None listed