Addition of Spironolactone in Patients With Resistant Arterial Hypertension

Phase 4

• Conditions: Hypertension
• Interventions: Drug: spironolactone

• Registration Number: NCT00524615
• Lead Sponsor: Jan Vaclavík

Brief 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.

Detailed Description

Arterial hypertension resistant to therapy and requiring treatment with more then three antihypertensive drugs is common. At present there are is no standard therapy for resistant hypertension based on randomised clinical trials, neither data to guide addition of further drugs to therapy. Recently some observational and retrospective trials reported good effect of spironolactone in patients with resistant hypertension, but these data were not validated by prospective randomised clinical trials.

This is a multicentric, randomised, double blind clinical trial, which will evaluate the effect of addition of 25 mg spironolactone to current medication compared to placebo. The study will enroll patients with blood pressure over 140/90 mmHg during a clinical examination, which are using at least three antihypertensive drugs, one of them being a diuretic. Average daytime systolic and diastolic blodd pressure will be evaluated by ABPM (ambulatory blood pressure monitoring).

Study Timeline

• Study First Submitted: 2007-08-31
• Study First Submitted QC: 2007-08-31
• Study Start: 2007-09
• Study First Posted: 2007-09-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-20
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	spironolactone	25 mg of Spironolactone oraly once daily
2	spironolactone	placebo oraly once daily

Primary Outcome Measures

Name	Time	Method
Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring)	before and after 2 months of treatment

Secondary Outcome Measures

Name	Time	Method
changes of serum potassium, natrium, creatinine, body weight, casual blood pressure in office, treatment response for different baseline levels of aldosterone and aldosterone/PRA ratio	2 months of follow-up

Trial Locations

Locations (1)

Olomouc University Hospital and Palacký University School of Medicine; 🇨🇿 Olomouc, Czech Republic