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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Ib Abildgaard Jacobsen, Odense University Hospital

ClinicalTrials.gov Identifier:

NCT01062763

First received: February 3, 2010

Last updated: December 7, 2011

Last verified: December 2011

History of Changes

Purpose

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

Condition	Intervention	Phase
Arterial Hypertension Resistant Hypertension Diabetes Mellitus Aldosterone Antagonism	Drug: spironolactone Drug: placebo	Phase 3

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines Diabetes High Blood Pressure

Drug Information available for: Spironolactone

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

Blood pressure reduction [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse effects [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	135
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)

Arms	Assigned Interventions
Experimental: addition of spironolactone spironolactone is added to previous antihypertensive treatment	Drug: spironolactone 25 to 50 mg once daily Other Name: Spirix Drug: placebo addition of placebo 1 to 2 tablets daily

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 NSAID or systemic glucocorticoids
Total cholesterol 10 mmol/l
NYHA class III and IV
Pregnancy or planned pregnancy
Psychiatric disease
Malignant disease
Insufficient adherence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062763

Sponsors and Collaborators

Ib Abildgaard Jacobsen

Investigators

Principal Investigator:

Ib A Jacobsen, DMSc

Odense University Hospital

More Information

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, Dahlof 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.

Responsible Party:	Ib Abildgaard Jacobsen, Consultant physician, associate professor, Odense University Hospital
ClinicalTrials.gov Identifier:	NCT01062763 History of Changes
Other Study ID Numbers:	EudraCT 2009-017033-22, 2009-017033-22
Study First Received:	February 3, 2010
Last Updated:	December 7, 2011
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:

hypertension
spironolactone
antihypertensive treatment
Type-2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Spironolactone

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on May 22, 2013

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