Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension (SPIRY)

Sobngwi Eugene

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus

Hypertension, Resistant to Conventional Therapy

Treatments

Drug: Low dose spironolactone

Other: Routine intensification of antihypertensive treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02426099

CNO22011

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No 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