Efficacy and Safety of Sacubitril/Valsartan in Maintenance Hemodialysis Patients With Heart Failure

  • STATUS
    Recruiting
  • participants needed
    104
  • sponsor
    Guangdong Provincial People's Hospital
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Updated on 5 August 2020
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systolic blood pressure
renal failure
cardiovascular disease
glomerular filtration rate
heart failure
ejection fraction
chronic disease
valsartan
angiotensin
nephropathy
ace inhibitor
angiotensin converting enzyme
enzyme inhibitors
chronic renal failure
kidney disease
chronic heart failure
sacubitril
maintenance hemodialysis
sacubitril/valsartan
entresto
angiotensin-converting enzyme inhibitors

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 strong level of recommendation (class I, level of evidence B) in the main international guidelines. Cardiovascular disease (CVD) is the most common cause of death in end stage renal disease (ESRD) patients undergoing hemodialysis (HD). Hence, treatments to improve mortality and specifically cardiovascular outcomes in this population are greatly needed. So far, no data available about the efficacy and safety of sacubitril/valsartan in ESRD patients undergoing hemodialysis, although this medication was noted to be effective and comparably well tolerable in those with estimated glomerular filtration rate(eGFR) 20 to 60 mL/min/1.73 m2 in the United Kingdom Heart and Renal Protection-III trial.

The purpose of this open label, randomized controlled study with prospective data collection is to assess the efficacy and safety of sacubitril/valsartan in maintenance hemodialysis patients with heart failure.

Details
Condition Heart failure, Heart failure, Heart disease, Heart disease, Hemodialysis Complication
Age 18years - 80years
Treatment Sacubitril / Valsartan Oral Tablet [Entresto], Benazepril 10mg Tablet
Clinical Study IdentifierNCT04458285
SponsorGuangdong Provincial People's Hospital
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Written informed consent obtained before any study assessment is performed
End stage renal disease (ESRD) patients (eGFR<15ml/min/1.73m 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 40%
Mean sitting systolic blood pressure(msSBP)140 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
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systolic blood pressure
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heart failure
ejection fraction
chronic disease
valsartan
angiotensin
nephropathy
ace inhibitor
angiotensin converting enzyme
enzyme inhibitors
chronic renal failure
kidney disease
chronic heart failure
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maintenance hemodialysis
sacubitril/valsartan
entresto
angiotensin-converting enzyme inhibitors

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