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

NCT03771729 | Unknown Early Phase 1 DMC

• 1 other identifier: 42411671-X
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CKD

Keywords

Sacubitril/Valsartan; Advanced CKD Patients; Heart Failure

Outcome Measures

Primary Outcomes (3)

• Change in estimated glomerular filtration rate(eGFR)

  Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .

  12 weeks

• Change in urinary microalbumin/creatinine ratio(uACR)

  Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks.

  12 weeks

• 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 Outcomes (8)

• blood uric acid

  12 weeks

• Rate of HbA1c

  12weeks

• Systolic and diastolic blood pressure

  12 weeks

• left ventricle eject fraction

  12 weeks

• Concentration of postassium

  12 weeks

Study Arms (1)

LCZ696 treatment

EXPERIMENTAL

LCZ696 200mg twice daily

Drug: LCZ 696

Interventions

LCZ 696 DRUG

LCZ696 200mg twice daily

Also known as: sacubitril/valsartan

LCZ696 treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Harbin Medical University: lead

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 11, 2018
• Study Start: December 30, 2018
• Primary Completion: May 28, 2019
• Study Completion: June 15, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-12