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

Phase 3

Completed

• Conditions: Arterial Hypertension; Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus
• Interventions: Drug: spironolactone; Drug: placebo

• Registration Number: NCT01062763
• Lead Sponsor: Ib Abildgaard Jacobsen

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Study Start: 2010-03
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Results First Submitted: 2013-06-27
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-08
• Last Update Submitted: 2014-04-08
• Results First Posted: 2014-05-08
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
addition of spironolactone	spironolactone	spironolactone is added to previous antihypertensive treatment
Placebo	placebo	Addition of placebo

Primary Outcome Measures

Name	Time	Method
Change of Diastolic Blood Pressure	4 months	Change of diastolic blood pressure from baseline to study end at four months.
Change of of Systolic Blood Pressure	4 months	Change of systolic blood pressure from baseline to study end at four months.

Secondary Outcome Measures

Name	Time	Method
Adverse Effects	4 months