The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension (SDHDS)

• ClinicalTrials.gov Identifier: NCT01062763
• Recruitment Status: Completed
• First Posted: February 4, 2010
• Results First Posted: May 8, 2014
• Last Update Posted: May 8, 2014
• Sponsor: Ib Abildgaard Jacobsen
• Information provided by (Responsible Party): Ib Abildgaard Jacobsen, Odense University Hospital

Study Description

Brief Summary:

The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.

Condition or disease	Intervention/treatment	Phase
Arterial Hypertension; Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus	Drug: spironolactone; Drug: placebo	Phase 3

Detailed Description:

The primary object of the study is to estimate the effect of addition of low dose spironolactone to antihypertensive treatment with at least three antihypertensive drugs in patients with type-2 diabetes and blood pressure over 130/80 mmHg.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: South Danish Hypertension and Diabetes Study
• Study Start Date: March 2010
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: May 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: addition of spironolactone; spironolactone is added to previous antihypertensive treatment	Drug: spironolactone; 25 to 50 mg once daily
Placebo Comparator: Placebo; Addition of placebo	Drug: placebo; addition of placebo 1 to 2 tablets daily

Outcome Measures

Primary Outcome Measures :

1. Change of of Systolic Blood Pressure [ Time Frame: 4 months ]
   Change of systolic blood pressure from baseline to study end at four months.
2. Change of Diastolic Blood Pressure [ Time Frame: 4 months ]
   Change of diastolic blood pressure from baseline to study end at four months.

Secondary Outcome Measures :

1. Adverse Effects [ Time Frame: 4 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age < 75 years
• Type-2 diabetes
• Therapy resistant hypertension (by ABPM)
• Treatment with at least 3 antihypertensives

Exclusion Criteria:

• HbA1c > 10.0
• 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

Contacts and Locations

Sponsors and Collaborators

Ib Abildgaard Jacobsen

Investigators

• Principal Investigator: Ib A Jacobsen, DMSc; Odense University Hospital

More Information

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: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.

• Responsible Party: Ib Abildgaard Jacobsen, Consultant physician, associate professor, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT01062763
• Other Study ID Numbers: EudraCT 2009-017033-22; 2009-017033-22 ( EudraCT Number )
• First Posted: February 4, 2010
• Results First Posted: May 8, 2014
• Last Update Posted: May 8, 2014
• Last Verified: April 2014

Keywords provided by Ib Abildgaard Jacobsen, Odense University Hospital:

hypertension; spironolactone; antihypertensive treatment; Type-2 diabetes

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Spironolactone; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents