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Addition of Spironolactone in Patients With Resistant Arterial Hypertension

2014-08-27 03:36:22 | BioPortfolio

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.

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Hypertension

Intervention

spironolactone

Location

Olomouc University Hospital and Palacký University School of Medicine
Olomouc
Czech Republic
775 20

Status

Recruiting

Source

University Hospital Olomouc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:36:22-0400

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PubMed Articles [1994 Associated PubMed Articles listed on BioPortfolio]

Renal denervation in comparison with intensified pharmacotherapy in true resistant hypertension: 2-year outcomes of randomized PRAGUE-15 study.

The randomized, multicentre study compared the efficacy of renal denervation (RDN) versus spironolactone addition in patients with true resistant hypertension. We present the 24-month data.

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THE ACUTE EFFECTS OF DIFFERENT SPIRONOLACTONE DOSES ON CARDIAC FUNCTION IN STREPTOZOTOCIN-INDUCED DIABETIC RATS.

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Stability of Spironolactone Oral Suspension in PCCA Base, SuspendIt.

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Medical and Biotech [MESH] Definitions

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Hypertension due to RENAL ARTERY OBSTRUCTION or compression.

A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827)

Increased pressure within the cranial vault. This may result from several conditions, including HYDROCEPHALUS; BRAIN EDEMA; intracranial masses; severe systemic HYPERTENSION; PSEUDOTUMOR CEREBRI; and other disorders.

Familial or idiopathic hypertension in the PULMONARY CIRCULATION which is not secondary to other disease.

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