Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension

NCT ID: NCT02426099

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low dose Spironolactone

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

Group Type: EXPERIMENTAL

Low dose spironolactone

Intervention Type: DRUG

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

Routine

Routine intensification of anti hypertensive treatment based on existing guidelines

Group Type: ACTIVE_COMPARATOR

Routine intensification of antihypertensive treatment

Intervention Type: OTHER

4-week guidelines oriented intensification of antihypertensive treatment

Interventions

Low dose spironolactone

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

Intervention Type: DRUG

Routine intensification of antihypertensive treatment

4-week guidelines oriented intensification of antihypertensive treatment

Intervention Type: OTHER

Other Intervention Names

Aldactone

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Yaounde 1

OTHER

Sponsor Role: collaborator

Sobngwi Eugene

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sobngwi Eugene

Professor and Consultant Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jean-Claude Mbanya, MD, PhD

Role: STUDY_CHAIR

University of Yaounde 1

Locations

National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Countries

Cameroon

References

Djoumessi RN, Noubiap JJ, Kaze FF, Essouma M, Menanga AP, Kengne AP, Mbanya JC, Sobngwi E. Effect of low-dose spironolactone on resistant hypertension in type 2 diabetes mellitus: a randomized controlled trial in a sub-Saharan African population. BMC Res Notes. 2016 Mar 23;9:187. doi: 10.1186/s13104-016-1987-5.

Reference Type: DERIVED

PMID: 27007793 (View on PubMed)

Other Identifiers

CNO22011

Identifier Type: -

Identifier Source: org_study_id