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

Sponsor

The Second Affiliated Hospital of Harbin Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03771729

Collaborator

(none)

Enrollment

Arm

5.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CKD	Drug: LCZ 696	Early Phase 1

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 30, 2018

Anticipated Primary Completion Date :

May 28, 2019

Anticipated Study Completion Date :

Jun 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LCZ696 treatment LCZ696 200mg twice daily	Drug: LCZ 696 LCZ696 200mg twice daily Other Names: sacubitril/valsartan

Arm

Intervention/Treatment

Experimental: LCZ696 treatment

LCZ696 200mg twice daily

Drug: LCZ 696

LCZ696 200mg twice daily

Other Names:

sacubitril/valsartan

Outcome Measures

Primary Outcome Measures

Change in estimated glomerular filtration rate(eGFR) [12 weeks]
Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .
Change in urinary microalbumin/creatinine ratio(uACR) [12 weeks]
Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks.
Concentration of N terminal pro B type natriuretic peptide(NT-prpBNP) [12 weeks]
Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic peptide(NT-proBNP) every 2weeks.

Secondary Outcome Measures

blood uric acid [12 weeks]
Blood samples will be collected for analysis of uric acid every 2weeks.
Rate of HbA1c [12weeks]
Blood samples will be collected for analysis of HbA1c every 2weeks.
Systolic and diastolic blood pressure [12 weeks]
Systolic and diastolic blood pressure will be measured every 2weeks.
left ventricle eject fraction [12 weeks]
Cardiac ultrasound will be measured every 2weeks.
Concentration of postassium [12 weeks]
Blood samples will be collected for analysis of concentration of postassium every 2weeks.
Concentration of serum troponin [12 weeks]
Blood samples will be collected for analysis of concentration of serum troponin every 2weeks.
Concentration of alanine aminotransferase or aspartate aminotransferase [12 weeks]
Blood samples will be collected for analysis of concentration of alanine aminotransferase or aspartate aminotransferase every 2weeks.
Concentration of sodio [12 weeks]
Urine samples will be collected for analysis of concentration of sodion every 2weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
acute renal failure
systolic blood pressure lower than 100 mm Hg at screening (<95 mm Hg at the randomisation visit)
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)
history of angioedema（drug-related or otherwise)
any medications that have potential for drug-drug interaction with LCZ696 will not be allowed during the study 7)pregnant female