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

• Status: Unknown status
• Trial end date: 2019-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Second Affiliated Hospital of Harbin Medical University
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

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