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
|Condition or disease||Intervention/treatment||Phase|
|Arterial Hypertension Hypertension, Resistant to Conventional Therapy Diabetes Mellitus||Drug: spironolactone Drug: placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||South Danish Hypertension and Diabetes Study|
|Study Start Date :||March 2010|
|Primary Completion Date :||March 2012|
|Study Completion Date :||May 2012|
Experimental: addition of spironolactone
spironolactone is added to previous antihypertensive treatment
25 to 50 mg once daily
Placebo Comparator: Placebo
Addition of placebo
addition of placebo 1 to 2 tablets daily
- Change of of Systolic Blood Pressure [ Time Frame: 4 months ]Change of systolic blood pressure from baseline to study end at four months.
- Change of Diastolic Blood Pressure [ Time Frame: 4 months ]Change of diastolic blood pressure from baseline to study end at four months.
- Adverse Effects [ Time Frame: 4 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062763
|Principal Investigator:||Ib A Jacobsen, DMSc||Odense University Hospital|