跳至主要内容
临床试验/CTRI/2020/02/023116
CTRI/2020/02/023116尚未招募1/2 期

Safety and efficacy of Sacubitril/Valsartan in control of resistant hypertension in CKD 5D patients

Postgraduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年10月2日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
入组人数
25
试验地点
1
主要终点
The safety of Sacubitril/Valsartan in CKD 5D patients

研究概览

简要总结

This is a prospective interventional study aimed to study the safety and efficacy of Sacubitril/Valsartan combination therapy in control of resistant hypertension in chronic kidney disease patients on hemodialysis. This study shall include patients aged more than 18 years undergoing hemodialysis and having urine output more than 200 ml/day. The primary and secondary objectives of the study shall be to assess safety and efficacy of Sacubitril/Valsartan respectively in control of resistant hypertension in CKD 5D patients. All patients fulfilling inclusion and exclusion criteria shall be given a run-in period of 2 weeks to exclude ’pseudoresistant’ hypertension by optimising their hemodialysis to achieve their dry body weight and ensuring a sodium restricted diet. Those patients having resistant hypertension post this run-in period shall be given Sacubitril/Valsartan therapy. These patients shall be given thrice a week hemodialysis at dialysis centre in PGIMER Chandigarh. The patients shall be regularly monitored with regards to their serum electrolytes, liver function tests and any adverse effects. The effectiveness of Sacubitril/Valsartan shall be studied with respect to control of office BP, ambulatory BP and if any change in echocardiographic parameters. Sacubitril/Valsartan combination therapy has stood as a potent antihypertensive in previous metanalysis and randomised trials assessing its efficacy in control of resistant hypertension in chronic kidney disease patients. Participation in the study is expected to be beneficial to the patients as control of their hypertension has definite cardiovascular mortality and morbidity benefits.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients declared as CKD 5D Aged >18 years Resistant hypertension Non oliguric Definitions CKD 5D- defined as hemodialysis dependence since last 3 months prior to screening Resistant hypertension- defined as uncontrolled hypertension SBP > 140 mm Hg or DBP >90 mm Hg despite use of 3 or more antihypertensive drugs including a diuretic Non oliguric- defined as urine output more than 200 ml per day.

排除标准

  • Serum potassium >5.5 mg/dl Not giving consent History of angioedema History of intolerance to ACE-inhibitors/ ARBs Associated heart failure with reduced ejection fraction Alanine aminotransferase or Aspartate aminotransferase >2 times the upper limit of the normal range Not willing for thrice a week hemodialysis.

结局指标

主要结局

The safety of Sacubitril/Valsartan in CKD 5D patients

时间窗: at the end of week-1/2/4/8/12

次要结局

  • To study efficacy of Sacubitril/Valsartan in control of resistant hypertension in CKD 5D patients(at the end of 3 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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