arterial hypertension resistant to treatment (target blood pressure not reached with a combination of at least three different antihypertensive drugs, one of them being a diuretic) MedDRA version: 9.1 Level: LLT Classification code 10020783 Term: Hypertension not adequately controlled MedDRA version: 9.1 Level: LLT Classification code 10020775 Term: Hypertension arterial MedDRA version: 9.1 Level: LLT Classification code 10038274 Term: Refractory hypertension
Conditions
Interventions
Trade Name: Verospiron tbl. 25 mg
Product Name: spironolactone
Pharmaceutical Form: Tablet
INN or Proposed INN: Spironolactone
Concentration unit: mg milligram(s)
Pharmaceutical form of the placebo: C
Sponsors
Olomouc University Hospital and Palacký University School of Medicine, Internal Medicine Dept. I
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only patients with resistant hypertension aged over 18 years will be enrolled. Resistant hypertension is defined as blood pressure during clinical control exceeding 140/90 mmHg (average of 2nd and 3rd measurement during one visit, with at least 3-5 minutes between separate measurements) despite adherence to treatment with full doses of at least three antihypertensive medications, including a diuretic. In diabetic patients or in patients with renal disease (i.e., with a creatinine level of more than 133 µmol per liter or urinary protein excretion of more than 300 mg over a 24-hour period) a blood pressure over 130/80 mmHg despite adherence to treatment with full doses of at least three antihypertensive medications including a diuretic is considered to be resistant. Patients will sign informed consent before enrollment to the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Following patients will not be enrolled: patients with grade 3 hypertension (systolic BP over 180 mmHg and/or diastolic over 110 mmHg) who need immediate treatment; patients with renal failure (acute or chronic) with creatinine exceeding 180 umol/l or glomerular filtration below 40 ml/min (based on MDRD calculation), hyperkalemia over 5,4 mmol/l, hyponatremia below 130 mmol/l, porphyria, hypersensitivity to components of the drug Verospiron (Richter Gedeon, Hungary), women in gravidity or lactation period or women in productive age not using any of contraceptive methods, and patients who already use any of the aldosterone antagonists (spironolactone, epleronone, kanreone).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary aims are to compare the changes of serum potassium, natrium, creatinine, microalbuminuria, body weight, and casual blood pressure in office between groups and to assess the treatment response in different baseline levels of aldosterone and aldosterone/PRA ratio.;Primary end point(s): Difference between the fall of average daily systolic and diastolic blood pressure measured by ABPM (ambulatory blood pressure monitoring) at the start of the study and after 8 weeks in groups treated by spironolactone and placebo.;Main Objective: The primary aim is to show a statistically significant difference between the fall of average daily systolic and diastolic blood pressure measured by ABPM (ambulatory blood pressure monitoring) at the start of the study and after 8 weeks in groups treated by spironolactone and placebo. | — |
Countries
Czech Republic
Outcome results
None listed