Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Efficacy (Blood pressure reduction)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resistant hypertension
- •Diabetes mellitus
排除标准
- •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
研究组 & 干预措施
Low dose Spironolactone
Add-on low dose 25 mg Spironolactone to current hypertension treatment
干预措施: Low dose spironolactone (Drug)
Routine
Routine intensification of anti hypertensive treatment based on existing guidelines
干预措施: Routine intensification of antihypertensive treatment (Other)
结局指标
主要结局
Efficacy (Blood pressure reduction)
时间窗: 4 weeks
Blood pressure reduction
次要结局
- Potassium (Change in serum potassium)(4 weeks)
- Creatinine (Change in serum creatinine)(4 weeks)
研究者
Sobngwi Eugene
Professor and Consultant Physician
Yaounde Central Hospital