Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sacubitril/Valsartan, Conventional anti-heart failure therapy.
- Who it may be relevant to
- Registry conditions: Sacubitril/Valsartan, Prosthetic Heart Valve, Heart Failure, Reduced Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
Overview
This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
Detailed description
Heart failure (HF) is the end stage of various types of cardiovascular disease. The prevalence of HF continues to rise, and the rates of readmission and mortality also continue to increase significantly.
There are three types of HF, heart failure with preserved ejection fraction (HFpEF), heart failure with mid-range ejection fraction (HFmrEF), and heart failure with reduced ejection fraction (HFrEF).
Sacubitril/valsartan, the first angiotensin receptor-neprilysin inhibitor (ARNI) approved by the FDA for the treatment of HFrEF, demonstrated significant benefits in the PARADIGM-HF trial. PARADIGM-HF trial was a large multicenter, randomized clinical trial comparing sacubitril/ valsartan with enalapril in patients with LVEF \< 40%. This trial showed 20% reduction in composite Cardiovascular (CV) death (including sudden cardiac death) and hospitalization for HF patients with S/V.
Interventions
- Drug Sacubitril/Valsartan
Patients 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) \[Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)\]. - Drug Conventional anti-heart failure therapy
Patients will be treated only with conventional anti-heart failure therapy as a control group.
Primary outcome measures
- Effective rate [Time frame: 6 months post-procedure]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Serum potassium >5.3 mmol/L.
- Severe pulmonary hypertension.
- Malignant arrhythmia.
- Malignant tumor.
- Known history of hereditary or primary angioedema.
- Serious adverse drug reactions or serious complications over the course of treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kafrelsheikh University — Kafr ash Shaykh
Identifiers
NCT: NCT07192341 · KFSIRB200-728