Status:
UNKNOWN
Efficacy and Safety of Sacubitril/Valsartan in Maintenance Hemodialysis Patients With Heart Failure
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Hemodialysis Complication
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Sacubitril/valsartan reduces the risk of cardiovascular mortality among patients with heart failure with reduced ejection fraction, and has been recently indicated as a new treatment option with a str...
Eligibility Criteria
Inclusion
- Written informed consent obtained before any study assessment is performed.
- End stage renal disease (ESRD) patients (eGFR\<15ml/min/1.73m² as measured by the Chronic Kidney Disease Epidemiology Collaboration formula at screening) who have been receiving hemodialysis 3 times a week for at least 12 weeks before registration.
- Chronic heart failure (NYHA class ≥ II) with reduced ejection fraction, defined as known LVEF ≤ 50%.
- Mean sitting systolic blood pressure(msSBP)≥110 mmHg.
- Use of angiotensin-converting enzyme inhibitors/angiotensin receptor blocker for at least 2 weeks.
- Good compliance.
Exclusion
- Acute renal failure with hemodialysis.
- Isolated right heart failure owing to pulmonary disease, primary cause of dyspnea due to noncardiac, non-HF causes such as acute or chronic respiratory disorders.
- Systolic blood pressure lower than 100 mmHg at screening (\<95 mmHg at the randomization visit).
- Previous history of intolerance to recommended target doses of angiotensin receptor blockers.
- 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 hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes.
- History of angioedema.
- Any medications that have potential for drug-drug interaction with LCZ696 will not be allowed during the study.
- Pregnant female.
- Use of sacubitril/valsartan prior to week-2.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04458285
Start Date
January 1 2020
End Date
December 31 2020
Last Update
October 6 2020
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080