The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension (SDHDS)
The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||South Danish Hypertension and Diabetes Study|
- Blood pressure reduction [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Adverse effects [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: addition of spironolactone
spironolactone is added to previous antihypertensive treatment
25 to 50 mg once daily
Other Name: SpirixDrug: placebo
addition of placebo 1 to 2 tablets daily
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.