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

NCT ID: NCT03771729

Last Updated: 2018-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-30
• Study Completion Date: 2019-06-15

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).

Conditions

CKD

Keywords

Sacubitril/Valsartan; Advanced CKD Patients; Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LCZ696 treatment

LCZ696 200mg twice daily

Group Type: EXPERIMENTAL

LCZ 696

Intervention Type: DRUG

LCZ696 200mg twice daily

Interventions

LCZ 696

LCZ696 200mg twice daily

Intervention Type: DRUG

Other Intervention Names

sacubitril/valsartan

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xuanyi Du

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

42411671-X

Identifier Type: -

Identifier Source: org_study_id