The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
NCT ID: NCT01062763
Last Updated: 2014-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
119 participants
INTERVENTIONAL
2010-03-31
2012-05-31
Brief Summary
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Detailed Description
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Secondary aims are to estimate how many of these patients have their blood pressure controlled by the addition of spironolactone, to investigate whether the addition of spironolactone affects insulin sensitivity and urinary protein secretion and to estimate the incidence of adverse effects of the aldosterone antagonist.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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addition of spironolactone
spironolactone is added to previous antihypertensive treatment
spironolactone
25 to 50 mg once daily
Placebo
Addition of placebo
placebo
addition of placebo 1 to 2 tablets daily
Interventions
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spironolactone
25 to 50 mg once daily
placebo
addition of placebo 1 to 2 tablets daily
Eligibility Criteria
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Inclusion Criteria
* Type-2 diabetes
* Therapy resistant hypertension (by ABPM)
* Treatment with at least 3 antihypertensives
Exclusion Criteria
* BP \> 180/110 mmHg
* Secondary hypertension
* Intolerance to spironolactone
* Permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids
* Total cholesterol 10 mmol/l
* New York Heart Association class III and IV
* Pregnancy or planned pregnancy
* Psychiatric disease
* Malignant disease
* Insufficient adherence
18 Years
75 Years
ALL
No
Sponsors
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Ib Abildgaard Jacobsen
OTHER
Responsible Party
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Ib Abildgaard Jacobsen
Consultant physician, associate professor
Principal Investigators
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Ib A Jacobsen, DMSc
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
References
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Elliott HL, Elawad M, Wilkinson R, Singh SP. Persistence of antihypertensive efficacy after missed doses: comparison of amlodipine and nifedipine gastrointestinal therapeutic system. J Hypertens. 2002 Feb;20(2):333-8. doi: 10.1097/00004872-200202000-00025.
Nishizaka MK, Zaman MA, Calhoun DA. Efficacy of low-dose spironolactone in subjects with resistant hypertension. Am J Hypertens. 2003 Nov;16(11 Pt 1):925-30. doi: 10.1016/s0895-7061(03)01032-x.
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.
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.
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Oxlund CS, Cangemi C, Henriksen JE, Jacobsen IA, Gram J, Schousboe K, Tarnow L, Argraves WS, Rasmussen LM. Low-dose spironolactone reduces plasma fibulin-1 levels in patients with type 2 diabetes and resistant hypertension. J Hum Hypertens. 2015 Jan;29(1):28-32. doi: 10.1038/jhh.2014.27. Epub 2014 Apr 17.
Other Identifiers
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2009-017033-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EudraCT 2009-017033-22
Identifier Type: -
Identifier Source: org_study_id
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