Addition of spironolactone in patients with resistant arterial hypertension (ASPIRANT) - ASPIRANT

• Conditions: 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: 9.1Level: LLTClassification code 10020783Term: Hypertension not adequately controlled; MedDRA version: 9.1Level: LLTClassification code 10020775Term: Hypertension arterial; MedDRA version: 9.1Level: LLTClassification code 10038274Term: Refractory hypertension

• Registration Number: EUCTR2007-003558-27-CZ
• Lead Sponsor: Olomouc University Hospital and Palacký University School of Medicine, Internal Medicine Dept. I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified