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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Kafrelsheikh University
  Kafr ash Shaykh, Kafrelsheikh, Egypt Recruiting

Study contacts

• Study coordinator: Mohammed A Hammad, MD
• Email: drhammad879@gmail.com
• Phone: 00201015928694

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.