Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension (SPIRY)
Primary Purpose
Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Cameroon
Study Type
Interventional
Intervention
Low dose spironolactone
Routine intensification of antihypertensive treatment
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension, Resistant to Conventional Therapy focused on measuring Resistant hypertension, diabetes mellitus, Spironolactone, African
Eligibility Criteria
Inclusion Criteria:
- Resistant hypertension
- Diabetes mellitus
Exclusion Criteria:
- T2DM with overt acute/chronic complications,
- serum potassium ≥ 5.5 mmol/l,
- estimated Glomerular Filtration Rate (eGFR) calculated using the Modification of Diet in Renal Disease formula ≤ 30 ml/min/1.73m² of body weight,
- absolute contraindication to any of the drug regimen of the trial,
- and current aldosterone antagonist treatment or cessation within the last 15 months
Sites / Locations
- National Obesity Centre, Yaounde Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low dose Spironolactone
Routine
Arm Description
Add-on low dose 25 mg Spironolactone to current hypertension treatment
Routine intensification of anti hypertensive treatment based on existing guidelines
Outcomes
Primary Outcome Measures
Efficacy (Blood pressure reduction)
Blood pressure reduction
Secondary Outcome Measures
Potassium (Change in serum potassium)
Change in serum potassium
Creatinine (Change in serum creatinine)
Change in serum creatinine
Full Information
NCT ID
NCT02426099
First Posted
April 21, 2015
Last Updated
April 23, 2015
Sponsor
Sobngwi Eugene
Collaborators
University of Yaounde 1
1. Study Identification
Unique Protocol Identification Number
NCT02426099
Brief Title
Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension
Acronym
SPIRY
Official Title
Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sobngwi Eugene
Collaborators
University of Yaounde 1
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a four-week randomized controlled single blinded trial of subjects presenting with resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to routine intensification of antihypertensive regimen , all added to previous regimen with unchanged diet. Visits are scheduled at the start of the treatment, at weeks two and four following add-on therapy initiation. The primary outcome is change in office and self-measurement blood pressure recorded at each visit, and secondary outcomes are variations in serum potassium, sodium, and creatinine levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus
Keywords
Resistant hypertension, diabetes mellitus, Spironolactone, African
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose Spironolactone
Arm Type
Experimental
Arm Description
Add-on low dose 25 mg Spironolactone to current hypertension treatment
Arm Title
Routine
Arm Type
Active Comparator
Arm Description
Routine intensification of anti hypertensive treatment based on existing guidelines
Intervention Type
Drug
Intervention Name(s)
Low dose spironolactone
Other Intervention Name(s)
Aldactone
Intervention Description
4-week add-on low dose spironolactone in resistant hypertension
Intervention Type
Other
Intervention Name(s)
Routine intensification of antihypertensive treatment
Intervention Description
4-week guidelines oriented intensification of antihypertensive treatment
Primary Outcome Measure Information:
Title
Efficacy (Blood pressure reduction)
Description
Blood pressure reduction
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Potassium (Change in serum potassium)
Description
Change in serum potassium
Time Frame
4 weeks
Title
Creatinine (Change in serum creatinine)
Description
Change in serum creatinine
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Resistant hypertension
Diabetes mellitus
Exclusion Criteria:
T2DM with overt acute/chronic complications,
serum potassium ≥ 5.5 mmol/l,
estimated Glomerular Filtration Rate (eGFR) calculated using the Modification of Diet in Renal Disease formula ≤ 30 ml/min/1.73m² of body weight,
absolute contraindication to any of the drug regimen of the trial,
and current aldosterone antagonist treatment or cessation within the last 15 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Claude Mbanya, MD, PhD
Organizational Affiliation
University of Yaounde 1
Official's Role
Study Chair
Facility Information:
Facility Name
National Obesity Centre, Yaounde Central Hospital
City
Yaounde
State/Province
Centre
Country
Cameroon
12. IPD Sharing Statement
Citations:
PubMed Identifier
27007793
Citation
Djoumessi RN, Noubiap JJ, Kaze FF, Essouma M, Menanga AP, Kengne AP, Mbanya JC, Sobngwi E. Effect of low-dose spironolactone on resistant hypertension in type 2 diabetes mellitus: a randomized controlled trial in a sub-Saharan African population. BMC Res Notes. 2016 Mar 23;9:187. doi: 10.1186/s13104-016-1987-5.
Results Reference
derived
Learn more about this trial
Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension
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