Addition of Spironolactone in Patients With Resistant Arterial Hypertension
NCT ID: NCT00524615
Last Updated: 2012-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
160 participants
INTERVENTIONAL
2007-09-30
2012-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
25 mg of Spironolactone oraly once daily
spironolactone
25 mg of spironolactone once daily or placebo for 2 months
2
placebo oraly once daily
spironolactone
25 mg of spironolactone once daily or placebo for 2 months
Interventions
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spironolactone
25 mg of spironolactone once daily or placebo for 2 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Czech Society of Hypertension
OTHER
Prostejov Hospital
UNKNOWN
Brno University Hospital
OTHER
Olomouc Military Hospital
UNKNOWN
Gedeon Richter Ltd.
INDUSTRY
Jan Vaclavík
OTHER
Responsible Party
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Jan Vaclavík
Principal investigator
Principal Investigators
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Jan Václavík, MD.
Role: STUDY_DIRECTOR
Internal medicine department I, Olomouc university hospital and Palacký University School of medicine
Bořek Lačňák, MD.
Role: PRINCIPAL_INVESTIGATOR
Internal Medicine Dept., Šternberk Hospital
Martin Plachý, MD.
Role: PRINCIPAL_INVESTIGATOR
Internal medicine department II, Brno University Hospital
Locations
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Olomouc University Hospital and Palacký University School of Medicine
Olomouc, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Jan Václavík, MD.
Role: primary
References
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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. doi: 10.1161/01.HYP.0000259805.18468.8c. 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. doi: 10.1016/j.amjhyper.2005.11.016.
Vaclavik J, Sedlak R, Jarkovsky J, Kocianova E, Taborsky M. Effect of spironolactone in resistant arterial hypertension: a randomized, double-blind, placebo-controlled trial (ASPIRANT-EXT). Medicine (Baltimore). 2014 Dec;93(27):e162. doi: 10.1097/MD.0000000000000162.
Vaclavik J, Sedlak R, Plachy M, Navratil K, Plasek J, Husar R, Kocianova E, Taborsky M. Addition of spironolactone in patients with resistant arterial hypertension (ASPIRANT)--study protocol. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011 Jun;155(2):143-8. doi: 10.5507/bp.155.2011.004.
Vaclavik J, Sedlak R, Plachy M, Navratil K, Plasek J, Jarkovsky J, Vaclavik T, Husar R, Kocianova E, Taborsky M. Addition of spironolactone in patients with resistant arterial hypertension (ASPIRANT): a randomized, double-blind, placebo-controlled trial. Hypertension. 2011 Jun;57(6):1069-75. doi: 10.1161/HYPERTENSIONAHA.111.169961. Epub 2011 May 2.
Related Links
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Palacký University School of Medicine
Olomouc University Hospital
Other Identifiers
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EudraCT 2007-003558-27
Identifier Type: -
Identifier Source: secondary_id
ASPIRANT-1
Identifier Type: -
Identifier Source: org_study_id
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