RecruitingNot ApplicableNCT07192341

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

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


Sponsor

Kafrelsheikh University

Enrollment

220 participants

Start Date

Sep 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether sacubitril/valsartan (a combination heart failure drug) is safe and helpful for people who have an artificial heart valve and also have heart failure with a weakened heart pump. **You may be eligible if...** - You are 18 years of age or older - You have a prosthetic (artificial) heart valve - You have been diagnosed with heart failure with reduced ejection fraction — meaning your heart pumps less than 40% of its blood out with each beat - Your heart failure symptoms fall within NYHA class II–IV (ranging from mild symptoms during activity to symptoms at rest) **You may NOT be eligible if...** - Your blood pressure is unstable or too low (below 100/60 mmHg) - You have severe kidney impairment (eGFR below 30 mL/min) or severe liver disease - Your potassium level is too high (above 5.3 mmol/L) - You have severe pulmonary hypertension, dangerous heart rhythm problems, or a malignant tumor - You have a history of hereditary angioedema or prior serious reactions to study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacubitril/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) \[Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)\].

DRUGConventional anti-heart failure therapy

Patients will be treated only with conventional anti-heart failure therapy as a control group.


Locations(1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

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NCT07192341


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