Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension

Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02426099

Acronym

SPIRY

Enrollment

Registered

2015-04-24

Start date

2011-10-31

Completion date

2012-10-31

Last updated

2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Hypertension, Resistant to Conventional Therapy

Keywords

Resistant hypertension, diabetes mellitus, Spironolactone, African

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.

Interventions

DRUGLow dose spironolactone

4-week add-on low dose spironolactone in resistant hypertension

OTHERRoutine intensification of antihypertensive treatment

4-week guidelines oriented intensification of antihypertensive treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy (Blood pressure reduction)	4 weeks	Blood pressure reduction

Secondary

Measure	Time frame	Description
Potassium (Change in serum potassium)	4 weeks	Change in serum potassium
Creatinine (Change in serum creatinine)	4 weeks	Change in serum creatinine

Countries

Cameroon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026