Status:
UNKNOWN
Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
Lead Sponsor:
The Second Affiliated Hospital of Harbin Medical University
Conditions:
CKD
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
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 w...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03771729
Start Date
December 30 2018
End Date
June 15 2019
Last Update
December 11 2018
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