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

Diabetes Mellitus Clinical Trial

— SDHDS  

Official title:

South Danish Hypertension and Diabetes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062763
• Other study ID #: EudraCT 2009-017033-22
• Secondary ID: 2009-017033-22
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2010
• Last updated: April 8, 2014
• Start date: March 2010
• Est. completion date: May 2012

Study information

• Verified date: April 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Coronary Vasospasm
• Diabetes Mellitus
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Intervention

Drug:
• spironolactone
25 to 50 mg once daily
• placebo
addition of placebo 1 to 2 tablets daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ib Abildgaard Jacobsen

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of of Systolic Blood Pressure	Change of systolic blood pressure from baseline to study end at four months.	4 months	No
Primary	Change of Diastolic Blood Pressure	Change of diastolic blood pressure from baseline to study end at four months.	4 months	No
Secondary	Adverse Effects		4 months	Yes