Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension
Information source: Yaounde Central Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus
Intervention: Low dose spironolactone (Drug); Routine intensification of antihypertensive treatment (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Sobngwi Eugene Official(s) and/or principal investigator(s): Jean-Claude Mbanya, MD, PhD, Study Chair, Affiliation: University of Yaounde 1
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.
Clinical Details
Official title: Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy (Blood pressure reduction)
Secondary outcome: Potassium (Change in serum potassium)Creatinine (Change in serum creatinine)
Eligibility
Minimum age: 21 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
National Obesity Centre, Yaounde Central Hospital, Yaounde, Centre, Cameroon
Additional Information
Starting date: October 2011
Last updated: April 23, 2015
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