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Completed

NCT Number: NCT05243199

Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Hemodialysis or peritoneal dialysis CKD5 patients were randomly divided into Sacubitril/Valsartan and irbesartan treatment groups. Comparing the blood pressure, survival rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD dialysis combined with heart failure is superior to that of irbesartan.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
  • NT-proBNP ≥2000pg/ml.
  • hypertension
  • Voluntary informed consent.

Exclusion criteria

  • Unable to tolerate ACEI/ARB class antihypertensive drugs;
  • History of symptomatic hypotension/systolic blood pressure <100mmHg at screening;
  • Potassium >6.0mmol/L;
  • History of angioedema;
  • Abnormal liver function such as ALT and/or AST >=3 times normal upper limit (ULN), total bilirubin >= 2 times ULN;
  • Moderate to severe anemia (hemoglobin <80g/L);
  • Cardiac surgery/intervention/cardiac resynchronization therapy has been performed in the past 3 months or is planned in the next 12 months;
  • Newly found malignant tumor (within 3 years), or undergoing radiotherapy/chemotherapy;
  • Pregnant and lactating women, or those of childbearing age who are unable to guarantee effective contraception;
  • New and serious life-threatening infections;
  • Active infectious diseases such as active tuberculosis, active viral hepatitis and HIV infection;
  • Persons suffering from mental disorders and taking psychotropic drugs;
  • Patients with life expectancy less than 12 months;
  • The doctor assessed that the patient was not easy to follow up or had poor compliance and was not suitable for enrollment;
  • Patients who do not want to sign informed consent.

Treatment and study plan

sacubitril/valsartan

Drug

The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it (no follow-up exit criteria were found).

Other names: ARNI

Irbesartan

Drug

The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid.

Other names: ARB

Primary outcomes

  1. The effect of ARNI on blood pressure in patients with CKD who are on dialysis

    Time frame: 1 year

    The evaluation indicator include office blood pressure

Secondary outcomes

  1. The effect of ARNI on ambulatory blood pressure

    Time frame: 1 year

    The evaluation indicator include ambulatory blood pressure

  2. The effect of ARNI on cardiac function in patients with CKD who are on dialysis

    Time frame: 1 year

    The evaluation indicators include heart function-related indicators such as NT pro-BNP and EF value

  3. The safety of ARNI in patients with CKD who are on dialysis

    Time frame: 1 year

    The evaluation indicators incidence of death (including death from cardiovascular events or other causes), hyperkalemia and other adverse events.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2022
Registry last updated
Mar 17, 2023

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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