RecruitingRecruiting
Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
NCT07192341 · Kafrelsheikh University
In plain English
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Official title
Effect of Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
About this study
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.
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.
Study design
Enrollment target: 220 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-27
Estimated completion: 2026-02-01
Last updated: 2025-09-30
Interventions
Drug: Sacubitril/ValsartanDrug: Conventional anti-heart failure therapy
Primary outcomes
- • Effective rate (6 months post-procedure)
Sponsor
Kafrelsheikh University · other
Contacts & investigators
ContactMohammed A Hammad, MD · contact · drhammad879@gmail.com · 00201015928694
All locations (1)
Kafrelsheikh UniversityRecruiting
Kafr ash Shaykh, Kafrelsheikh, Egypt