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

April 23, 2015 updated by: Sobngwi Eugene

Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
    • Centre
      • Yaounde, Centre, Cameroon
        • National Obesity Centre, Yaounde Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose Spironolactone
Add-on low dose 25 mg Spironolactone to current hypertension treatment
Drug: Low dose spironolactone
4-week add-on low dose spironolactone in resistant hypertension
Other Names:
  • Aldactone
Active Comparator: Routine
Routine intensification of anti hypertensive treatment based on existing guidelines
Other: Routine intensification of antihypertensive treatment
4-week guidelines oriented intensification of antihypertensive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy (Blood pressure reduction)
Time Frame: 4 weeks
Blood pressure reduction
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potassium (Change in serum potassium)
Time Frame: 4 weeks
Change in serum potassium
4 weeks
Creatinine (Change in serum creatinine)
Time Frame: 4 weeks
Change in serum creatinine
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sobngwi Eugene

Collaborators

University of Yaounde 1

Investigators

  • Study Chair: Jean-Claude Mbanya, MD, PhD, University of Yaounde 1

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNO22011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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