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

Ib Abildgaard Jacobsen

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus

Arterial Hypertension

Hypertension, Resistant to Conventional Therapy

Treatments

Drug: placebo

Drug: spironolactone

Study type

Interventional

Funder types

Other

Identifiers

NCT01062763

2009-017033-22 (EudraCT Number)

EudraCT 2009-017033-22

Details and patient eligibility

About

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

Full 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.

Enrollment

119 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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