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Addition of Spironolactone in Patients With Resistant Arterial Hypertension

Information source: University Hospital Olomouc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: spironolactone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Jan Vaclavk

Official(s) and/or principal investigator(s):
Jan Václavík, MD., Study Director, Affiliation: Internal medicine department I, Olomouc university hospital and Palacký University School of medicine
Bořek Lačňák, MD., Principal Investigator, Affiliation: Internal Medicine Dept., Šternberk Hospital
Martin Plachý, MD., Principal Investigator, Affiliation: Internal medicine department II, Brno University Hospital

Overall contact:
Jan Václavík, MD., Phone: +420588443209, Email: vaclavk.j@centrum.cz

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.

Clinical Details

Official title: Addition of Spironolactone in Patients With Resistant Arterial Hypertension

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

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

Secondary outcome: 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

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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Jan Václavík, MD., Phone: +420588443209, Email: vaclavk.j@centrum.cz

Olomouc University Hospital and Palacký University School of Medicine, Olomouc 775 20, Czech Republic; Recruiting
Jan Václavík, MD.
Jan Václavík, MD., Principal Investigator
Additional Information

Palacký University School of Medicine

Olomouc University Hospital

Related publications:

Chapman N, Dobson J, Wilson S, Dahlöf B, Sever PS, Wedel H, Poulter NR; Anglo-Scandinavian Cardiac Outcomes Trial Investigators. Effect of spironolactone on blood pressure in subjects with resistant hypertension. Hypertension. 2007 Apr;49(4):839-45. Epub 2007 Feb 19.

Sharabi Y, Adler E, Shamis A, Nussinovitch N, Markovitz A, Grossman E. Efficacy of add-on aldosterone receptor blocker in uncontrolled hypertension. Am J Hypertens. 2006 Jul;19(7):750-5.

Starting date: September 2007
Last updated: June 19, 2012

Page last updated: August 23, 2015

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