Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension

Phase 4

Completed

• Conditions: Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus
• Interventions: Drug: Low dose spironolactone; Other: Routine intensification of antihypertensive treatment

• Registration Number: NCT02426099
• Lead Sponsor: Sobngwi Eugene

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-04
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-23
• Last Update Submitted: 2015-04-23
• Study First Posted: 2015-04-24
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose Spironolactone	Low dose spironolactone	Add-on low dose 25 mg Spironolactone to current hypertension treatment
Routine	Routine intensification of antihypertensive treatment	Routine intensification of anti hypertensive treatment based on existing guidelines

Primary Outcome Measures

Name	Time	Method
Efficacy (Blood pressure reduction)	4 weeks	Blood pressure reduction

Secondary Outcome Measures

Name	Time	Method
Potassium (Change in serum potassium)	4 weeks	Change in serum potassium
Creatinine (Change in serum creatinine)	4 weeks	Change in serum creatinine

Trial Locations

Locations (1)

National Obesity Centre, Yaounde Central Hospital; 🇨🇲 Yaounde, Centre, Cameroon