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

CKD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03771729
• Other study ID #: 42411671-X
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 30, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: December 2018
• Source: The Second Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 15, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• CKD
• Heart Failure
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• LCZ 696
LCZ696 200mg twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Harbin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in estimated glomerular filtration rate(eGFR)	Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .	12 weeks
Primary	Change in urinary microalbumin/creatinine ratio(uACR)	Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks.	12 weeks
Primary	Concentration of N terminal pro B type natriuretic peptide(NT-prpBNP)	Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic peptide(NT-proBNP) every 2weeks.	12 weeks
Secondary	blood uric acid	Blood samples will be collected for analysis of uric acid every 2weeks.	12 weeks
Secondary	Rate of HbA1c	Blood samples will be collected for analysis of HbA1c every 2weeks.	12weeks
Secondary	Systolic and diastolic blood pressure	Systolic and diastolic blood pressure will be measured every 2weeks.	12 weeks
Secondary	left ventricle eject fraction	Cardiac ultrasound will be measured every 2weeks.	12 weeks
Secondary	Concentration of postassium	Blood samples will be collected for analysis of concentration of postassium every 2weeks.	12 weeks
Secondary	Concentration of serum troponin	Blood samples will be collected for analysis of concentration of serum troponin every 2weeks.	12 weeks
Secondary	Concentration of alanine aminotransferase or aspartate aminotransferase	Blood samples will be collected for analysis of concentration of alanine aminotransferase or aspartate aminotransferase every 2weeks.	12 weeks
Secondary	Concentration of sodio	Urine samples will be collected for analysis of concentration of sodion every 2weeks.	12 weeks