Trial | NCT02426099  Report issue

Title

Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension
Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    spironolactone ...

  • Study Participants

    17
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.
Study Started
Oct 31
2011
Primary Completion
Oct 31
2012
Study Completion
Oct 31
2012
Last Update
Apr 24
2015
Estimate

Drug Low dose spironolactone

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

  • Other names: Aldactone

Other Routine intensification of antihypertensive treatment

4-week guidelines oriented intensification of antihypertensive treatment

Low dose Spironolactone Experimental

Add-on low dose 25 mg Spironolactone to current hypertension treatment

Routine Active Comparator

Routine intensification of anti hypertensive treatment based on existing guidelines

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
No Results Posted