Addition of Spironolactone in Patients With Resistant Arterial Hypertension

Jan Vaclavík160 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

Hypertension

Interventions

spironolactoneDRUG

25 mg of spironolactone once daily or placebo for 2 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Olomouc University Hospital and Palacký University School of Medicine

Olomouc, Czechia

RECRUITING

Outcomes

Primary Outcomes

Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring)

Time frame: before and after 2 months of treatment

Secondary Outcomes

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

Time frame: 2 months of follow-up

Central Contacts

Jan Václavík, MD.

CONTACT

+420588443209 vaclavk.j@centrum.cz

Data from ClinicalTrials.gov

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