Efficacy and Safety of Sacubitril/Valsartan in Maintenance Hemodialysis Patients With Heart Failure (ESARHD-HF)

This is an interventional treatment trial for Hemodialysis Complication focused on measuring Sacubitril/valsartan, valsartan, Hemodialysis, Heart failure Read More

Inclusion Criteria:

• 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 Criteria:

• 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.