Sacubitril/valsartan for people with prosthetic heart valves and reduced ejection fraction

Effect of Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction

This trial will test whether sacubitril/valsartan helps people with prosthetic heart valves who have heart failure with reduced ejection fraction.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kafrelsheikh University (other)
• Locations: 1 site (Kafr ash Shaykh, Kafrelsheikh)
• Trial ID: NCT07192341 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls adults with prosthetic heart valves who have HFrEF (LVEF ≤40% and NYHA class II–IV) and compares sacubitril/valsartan with conventional heart-failure therapy. Participants will receive sacubitril/valsartan or usual anti‑heart failure treatments with follow-up to monitor symptoms, left ventricular function, hospitalizations, and adverse events. Key exclusions include hemodynamic instability, severe renal or hepatic dysfunction, low blood pressure, hyperkalemia, severe pulmonary hypertension, malignant arrhythmia, or angioedema history. The study is conducted at Kafrelsheikh University and uses on‑site enrollment and follow‑up visits to capture clinical and safety outcomes.

Who should consider this trial

Good fit: Adults with a history of prosthetic heart valves and HFrEF (LVEF ≤40% and NYHA class II–IV) who are hemodynamically stable and meet renal and hepatic function criteria.

Not a fit: Patients with hemodynamic instability, severe renal or hepatic impairment, low blood pressure, high potassium, severe pulmonary hypertension, malignant arrhythmia, or a history of angioedema are unlikely to benefit or may be excluded for safety.

Why it matters

Potential benefit: If successful, this could improve symptoms and reduce hospitalizations and cardiovascular deaths in patients with prosthetic valves and HFrEF.

How similar studies have performed: Sacubitril/valsartan showed clear benefit in broad HFrEF populations in PARADIGM‑HF, but its specific effects in patients with prosthetic heart valves have not been well studied.

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.

Where this trial is running

Kafr ash Shaykh, Kafrelsheikh

• Kafrelsheikh University — Kafr ash Shaykh, Kafrelsheikh, Egypt (RECRUITING)

Study contacts

• Study coordinator: Mohammed A Hammad, MD

Conditions: Sacubitril/Valsartan, Prosthetic Heart Valve, Heart Failure, Reduced Ejection Fraction