Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde

Conditions
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Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus

Intervention / Treatment
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* Drug: Low dose spironolactone
* Other: Routine intensification of antihypertensive treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose Spironolactone<br>Add-on low dose 25 mg Spironolactone to current hypertension treatment | Drug: Low dose spironolactone<br>* 4-week add-on low dose spironolactone in resistant hypertension<br>* Other names: Aldactone;|
| Active Comparator: Routine<br>Routine intensification of anti hypertensive treatment based on existing guidelines | Other: Routine intensification of antihypertensive treatment<br>* 4-week guidelines oriented intensification of antihypertensive treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (Blood pressure reduction) | Blood pressure reduction | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potassium (Change in serum potassium) | Change in serum potassium | 4 weeks | 
| Creatinine (Change in serum creatinine) | Change in serum creatinine | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistant hypertension, diabetes mellitus, Spironolactone, African