NCT02426099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

April 21, 2015

Last Update Submit

April 23, 2015

Conditions

Hypertension, Resistant to Conventional TherapyDiabetes Mellitus

Keywords

Resistant hypertensiondiabetes mellitusSpironolactoneAfrican

Outcome Measures

Primary Outcomes (1)

  • Efficacy (Blood pressure reduction)

    Blood pressure reduction

    4 weeks

Secondary Outcomes (2)

  • Potassium (Change in serum potassium)

    4 weeks

  • Creatinine (Change in serum creatinine)

    4 weeks

Study Arms (2)

Low dose Spironolactone

EXPERIMENTAL

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

Drug: Low dose spironolactone

Routine

ACTIVE COMPARATOR

Routine intensification of anti hypertensive treatment based on existing guidelines

Other: Routine intensification of antihypertensive treatment

Interventions

Low dose spironolactoneDRUG

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

Also known as: Aldactone
Low dose Spironolactone
Routine intensification of antihypertensive treatmentOTHER

4-week guidelines oriented intensification of antihypertensive treatment

Routine

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resistant hypertension
  • Diabetes mellitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Location

Related Publications (1)

  • 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.

    PMID: 27007793DERIVED

MeSH Terms

Conditions

Hypertension Resistant to Conventional TherapyDiabetes Mellitus

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jean-Claude Mbanya, MD, PhD

    University of Yaounde 1

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Consultant Physician

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

CA(1)