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Safety and efficacy of Sacubitril/Valsartan in blood pressure control of dialysis patients

Phase 1
Conditions
Health Condition 1: N186- End stage renal disease
Registration Number
CTRI/2020/02/023116
Lead Sponsor
Postgraduate Institute of Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The safety of Sacubitril/Valsartan in CKD 5D patientsTimepoint: at the end of week-1/2/4/8/12
Secondary Outcome Measures
NameTimeMethod
To study efficacy of Sacubitril/Valsartan in control of resistant hypertension in CKD 5D patientsTimepoint: at the end of 3 months
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