Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKafrelsheikh University
About this trial
This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old.
Both sexes.
Patients with a history of prosthetic heart valves.
Patients diagnosed with heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 40% with New York Heart Association (NYHA) functional class II-IV.
Disqualifiers
Hemodynamic instability.
Use of a circulatory auxiliary circulation device.
Severe hepatic [alanine aminotransferase (ALT) >120 U/L] and renal insufficiency [estimated glomerular filtration rate (eGFR) <30 mL/min].
Blood pressure <100/60 mmHg.
Trial design
Design model
Parallel
Treatments tested in this trial
Sacubitril/Valsartan
DrugPatients will be treated with conventional anti-heart failure therapy plus sacubitril/valsartan (oral administration of an initial dose of 24/26 mg twice daily, gradually increasing to 97/103 mg, depending on follow-up blood pressure) \[Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)\].
Conventional anti-heart failure therapy
DrugPatients will be treated only with conventional anti-heart failure therapy as a control group.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Group SExperimental treatment 1 intervention
Group B: Group CActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effective rate
Effectiveness is defined as an New York Heart Association (NYHA) cardiac function grade improved by 1 grade or more. Effective rate= Effectiveness/total quantity\*(100%).
Time frame
6 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov