Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension

Diabetes Mellitus Clinical Trial

— SPIRY  

Official title:

Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426099
• Other study ID #: CNO22011
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2015
• Last updated: April 23, 2015
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: April 2015
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Vasospasm
• Diabetes Mellitus
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Intervention

Drug:
• Low dose spironolactone
4-week add-on low dose spironolactone in resistant hypertension

Other:
• Routine intensification of antihypertensive treatment
4-week guidelines oriented intensification of antihypertensive treatment

Locations

Country	Name	City	State
Cameroon	National Obesity Centre, Yaounde Central Hospital	Yaounde	Centre

Sponsors (2)

Lead Sponsor	Collaborator
Sobngwi Eugene	University of Yaounde 1

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (Blood pressure reduction)	Blood pressure reduction	4 weeks	No
Secondary	Potassium (Change in serum potassium)	Change in serum potassium	4 weeks	Yes
Secondary	Creatinine (Change in serum creatinine)	Change in serum creatinine	4 weeks	Yes