Addition of Spironolactone in Patients With Resistant Arterial Hypertension

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of spironolactone on lowering blood pressure when added to therapy in patients with resistant arterial hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jan Vaclavík
• Collaborators: Brno University Hospital; Czech Society of Hypertension; Gedeon Richter Ltd.; Olomouc Military Hospital; Prostejov Hospital
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• Patients over 18 years

• Resistant arterial hypertension: (blood pressure during clinical control exceeding 140/90 mmHg (or 130/80 mmHg in in diabetic patients or patients with renal disease with creatinine level of more than 133 μmol per liter or urinary protein excretion of more than 300 mg over a 24-hour period) despite adherence to treatment with full doses of at least three antihypertensive medications, including a diuretic

Exclusion Criteria:

• Pregnant or breastfeeding women, women in fertile age without ruled out pregnancy

• Severe hypertension over 180/110 mmHg

• Renal insufficiency with creatinine over 180 umol/l or GFR lower than 40 ml/min

• Hyperkalemia over 5,4 mmol/l, hyponatremia below 130 mmol/l

• Porphyria

• Hypersensitivity to the compounds of Verospiron (Richter Gedeon, Hungary) drug

• Patients taking any aldosterone antagonist (spironolactone, eplerenone, kanreone)