Clinical trial NCT03771729: Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
Official title: Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: CKD
Keywords: Sacubitril/Valsartan
Advanced CKD Patients
Heart Failure
Lead sponsor: The Second Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in estimated glomerular filtration rate(eGFR)
timeFrame: 12 weeks
measure: Change in urinary microalbumin/creatinine ratio(uACR)
timeFrame: 12 weeks
measure: Concentration of N terminal pro B type natriuretic peptide(NT-prpBNP)
timeFrame: 12 weeks
Secondary outcomes:
measure: blood uric acid
timeFrame: 12 weeks
measure: Rate of HbA1c
timeFrame: 12weeks
measure: Systolic and diastolic blood pressure
timeFrame: 12 weeks
measure: left ventricle eject fraction
timeFrame: 12 weeks
measure: Concentration of postassium
timeFrame: 12 weeks
measure: Concentration of serum troponin
timeFrame: 12 weeks
measure: Concentration of alanine aminotransferase or aspartate aminotransferase
timeFrame: 12 weeks
measure: Concentration of sodio
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
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