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

Condition(s) targeted: Arterial Hypertension; Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus

Intervention: spironolactone (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ib Abildgaard Jacobsen

Official(s) and/or principal investigator(s):
Ib A Jacobsen, DMSc, Principal Investigator, Affiliation: Odense University Hospital

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

Official title: South Danish Hypertension and Diabetes Study

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

Primary outcome:

Change of of Systolic Blood Pressure

Change of Diastolic Blood Pressure

Secondary outcome: Adverse Effects

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Related 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.

Starting date: March 2010
Last updated: April 8, 2014