Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure

Harbin Medical University

Status and phase: Unknown; Early Phase 1

Conditions: CKD

Treatments: Drug: LCZ 696

Study type: Interventional

Funder types: Other

Identifiers

NCT03771729

42411671-X

Details and patient eligibility

About

This paper will mainly present the renal results from a clinical study aimed to observe the effect of sacubitril/valsartan in advanced chronic kedney disease patients with heart failure.All patients will receive LCZ696.The results will be compared before and after treatment.

Full description

On trial entry, patients will first receive LCZ696 50mg twice daily.According to the condition of disease and tolerance,the dose will be doubled every 2 weeks until the target maintenance dose 200mg twice daily is reached unless potassium or change in kidney function preclude a dose increase(reduction in dose will be permitted if the larger dose will not be tolerated, and temporary interruption will be permitted at any time if required for clinical reasons).The trial will be followed up for 12 weeks. Study visits will be scheduled at 2,4,6,8,10and12 weeks (and additional visits will be arranged where necessary to monitor participant safety).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients diagnosed with Chronic kidney disease (eGFR<60 ml/ min/1.73m²) and heart failure
2. documented history of heart failure with associated signs or symptoms
3. New York Heart Association (NYHA) classes II-IV
4. mean sitting systolic blood pressure (msSBP) ⩾140mmHg
5. good compliance

Exclusion criteria

1. isolated right heart failure owing to pulmonary disease, dyspnoea from non-cardiac causes, primary valvular or myocardial diseases, or coronary or cerebrovascular diseases needing revascularization within 3months of screening or during the trial
2. acute renal failure
3. systolic blood pressure lower than 100 mm Hg at screening (<95 mm Hg at the randomisation visit)
4. significant laboratory abnormalities at screening interfering with assessment of study drug safety or efficacy(such as serum potassium>5.5 or <3.5mmol/L, serum sodium<130mmol/L or alanine aminotransferase or aspartate aminotransferase>2 times the upper limit of the normal range)
5. history of angioedema（drug-related or otherwise)
6. any medications that have potential for drug-drug interaction with LCZ696 will not be allowed during the study 7)pregnant female

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

LCZ696 treatment

Experimental group

Description:

LCZ696 200mg twice daily

Treatment:

Drug: LCZ 696