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

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

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023116
Enrollment
25
Registered
2020-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: Sacubitril/Valsartan: Angiotensin receptor- Neprilysin inhibitor Intervention2: Sacubitril/Valsartan: Sacubitril/Valsartan is a angiotensin receptor blocker-neprilysin inhibitor combina

Sponsors

Postgraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The safety of Sacubitril/Valsartan in CKD 5D patientsTimepoint: at the end of week-1/2/4/8/12

Secondary

MeasureTime frame
To study efficacy of Sacubitril/Valsartan in control of resistant hypertension in CKD 5D patientsTimepoint: at the end of 3 months

Countries

India

Contacts

Public ContactDr Manish Rathi

PGIMER Chandigarh

drmanishrathi@gmail.com00919216721287

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026