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Completed

NCT Number: NCT02426099

Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension

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.

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Key information

Conditions

Hypertension, Resistant to Conventional Therapy Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Resistant to Conventional Therapy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose spironolactone

Drug

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

Other names: Aldactone

Routine intensification of antihypertensive treatment

Other

4-week guidelines oriented intensification of antihypertensive treatment

Primary outcomes

  1. Efficacy (Blood pressure reduction)

    Time frame: 4 weeks

    Blood pressure reduction

Secondary outcomes

  1. Potassium (Change in serum potassium)

    Time frame: 4 weeks

    Change in serum potassium

  2. Creatinine (Change in serum creatinine)

    Time frame: 4 weeks

    Change in serum creatinine

Sponsors and collaborators

Lead sponsor

Sobngwi Eugene

Other Gov

Collaborators

  • University of Yaounde 1

Registry information

Official study title

Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde

Acronym: SPIRY

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 24, 2015
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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