Addition of Spironolactone in Patients With Resistant Arterial Hypertension

Study Overview
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Brief Summary
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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
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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).

Official Title
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Addition of Spironolactone in Patients With Resistant Arterial Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: spironolactone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>25 mg of Spironolactone oraly once daily | Drug: spironolactone<br>* 25 mg of spironolactone once daily or placebo for 2 months<br>|
| Placebo Comparator: 2<br>placebo oraly once daily | Drug: spironolactone<br>* 25 mg of spironolactone once daily or placebo for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring) |  | before and after 2 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resistant hypertension treatment, spironolactone, aldosterone antagonists, resistant arterial hypertension, refractory arterial hypertension