Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
Recruiting · NCT07192341 · Interventional (participants receive a specific treatment) · Lead sponsor: Kafrelsheikh University
View the official record on ClinicalTrials.gov →Interventions studied
Conventional anti-heart failure therapySacubitril/Valsartan
What this trial is about
This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Kafrelsheikh University - Kafr ash Shaykh, Kafrelsheikh, Egypt