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

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ClinicalTrials.gov Identifier: NCT01062763
Recruitment Status : Completed
First Posted : February 4, 2010
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Ib Abildgaard Jacobsen, Odense University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Arterial Hypertension
Hypertension, Resistant to Conventional Therapy
Diabetes Mellitus
Interventions Drug: spironolactone
Drug: placebo
Enrollment 119
Recruitment Details Patients recruited from outpatient clinics of endocrinology at two university hospitals and two general hospitals in the period from May 2010 to March 2012.
Pre-assignment Details 163 patints screened. 44 screenfailures due to exclusion criteria as indicated. 119 randomized
Arm/Group Title Placebo Addition of Spironolactone
Hide Arm/Group Description 1tablet of matching placebo trated up to 2 if neccessary

spironolactone is added to previous antihypertensive treatment

placebo : addition of placebo 1 to 2 tablets daily

spironolactone : 25 to 50 mg once daily

Period Title: Overall Study
Started 58 [1] 61
Completed 55 57
Not Completed 3 4
Reason Not Completed
Adverse Event             3             4
[1]
119 randomized.
Arm/Group Title Addition of Spironolactone Placebo Total
Hide Arm/Group Description

spironolactone is added to previous antihypertensive treatment

placebo : addition of placebo 1 to 2 tablets daily

spironolactone : 25 to 50 mg once daily

[Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 61 58 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
  55.7%
28
  48.3%
62
  52.1%
>=65 years
27
  44.3%
30
  51.7%
57
  47.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 58 participants 119 participants
62.9  (7.1) 63.9  (6.9) 63.4  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
Female
15
  24.6%
13
  22.4%
28
  23.5%
Male
46
  75.4%
45
  77.6%
91
  76.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 61 participants 58 participants 119 participants
61 58 119
1.Primary Outcome
Title Change of of Systolic Blood Pressure
Hide Description Change of systolic blood pressure from baseline to study end at four months.
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis by intention to treat using LOCF
Arm/Group Title Addition of Spironolactone Placebo
Hide Arm/Group Description:

spironolactone is added to previous antihypertensive treatment

spironolactone : 25 uptrated if necessary to 50 mg once daily

1tablet of matching placebo uptrated to 2 if neccessary
Overall Number of Participants Analyzed 57 55
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
-9.6
(-12.8 to -6.3)
-0.7
(-3.3 to 2.0)
2.Primary Outcome
Title Change of Diastolic Blood Pressure
Hide Description Change of diastolic blood pressure from baseline to study end at four months.
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyzed by intention to treat and last observation carried forward
Arm/Group Title Addition of Spironolactone Placebo
Hide Arm/Group Description:

spironolactone is added to previous antihypertensive treatment

spironolactone : 25 uptrated if necessary to 50 mg once daily

1tablet of matching placebo uptrated to 2 if neccessary
Overall Number of Participants Analyzed 57 55
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
-3.9
(-6.0 to -2.0)
-0.3
(-1.8 to 1.3)
3.Secondary Outcome
Title Adverse Effects
Hide Description [Not Specified]
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Addition of Spironolactone Placebo
Hide Arm/Group Description:

spironolactone is added to previous antihypertensive treatment

spironolactone : 25 uptrated if necessary to 50 mg once daily

1tablet of matching placebo uptrated to 2 if neccessary
Overall Number of Participants Analyzed 61 58
Measure Type: Number
Unit of Measure: participants
4 0
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Addition of Spironolactone Placebo
Hide Arm/Group Description

spironolactone is added to previous antihypertensive treatment

spironolactone : 25 uptrated if necessary to 50 mg once daily

1tablet of matching placebo uptrated to 2 if neccessary
All-Cause Mortality
Addition of Spironolactone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Addition of Spironolactone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/61 (1.64%)      0/58 (0.00%)    
Blood and lymphatic system disorders     
Serious hyperkalemia  [1]  1/61 (1.64%)  1 0/58 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Plasma potasium above 5.5 mmol/l
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Addition of Spironolactone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/61 (0.00%)      0/58 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ib A. Jacobsen
Organization: Dept. of Endocrinology, Odense University Hospital
Phone: +45 27203135
Responsible Party: Ib Abildgaard Jacobsen, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01062763     History of Changes
Other Study ID Numbers: EudraCT 2009-017033-22
2009-017033-22 ( EudraCT Number )
First Submitted: February 3, 2010
First Posted: February 4, 2010
Results First Submitted: June 27, 2013
Results First Posted: May 8, 2014
Last Update Posted: May 8, 2014