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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ib Abildgaard Jacobsen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01062763
First received: February 3, 2010
Last updated: April 8, 2014
Last verified: April 2014
  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
Hypertension, Resistant to Conventional Therapy
Diabetes Mellitus
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, Caregiver, Investigator, Outcomes Assessor)
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:
  • Change of of Systolic Blood Pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change of systolic blood pressure from baseline to study end at four months.

  • Change of Diastolic Blood Pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change of diastolic blood pressure from baseline to study end at four months.


Secondary Outcome Measures:
  • Adverse Effects [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 119
Study Start Date: March 2010
Study Completion Date: May 2012
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
Placebo Comparator: Placebo
Addition of placebo
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: June 27, 2013
Last Updated: April 8, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
hypertension
spironolactone
antihypertensive treatment
Type-2 diabetes

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014