Addition of Spironolactone in Patients With Resistant Arterial Hypertension
Information source: University Hospital Olomouc
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: spironolactone (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University Hospital Olomouc 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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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
Additional Information
Palacký University School of Medicine Olomouc University Hospital
Related publications: Chapman N, Dobson J, Wilson S, Dahlof 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
Ending date: August 2008
Last updated: August 31, 2007
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