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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Odense University Hospital.
Recruitment status was  Active, not recruiting
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
  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:


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:
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 April 16, 2014