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NCT Number: NCT07192341

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location status: Recruiting

Location contact

Mohamed K Salama, MD

PRINCIPAL_INVESTIGATOR

Mohammed A Hammad, MD

CONTACT

[email protected]

00201015928694

Wael A Hassib, MD

PRINCIPAL_INVESTIGATOR

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sacubitril/valsartan

Drug

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)].

Conventional anti-heart failure therapy

Drug

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

Primary outcomes

  1. Effective rate

    Time frame: 6 months post-procedure

    Effectiveness is defined as an New York Heart Association (NYHA) cardiac function grade improved by 1 grade or more.

    Effective rate= Effectiveness/total quantity*(100%).

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed A Hammad, MD

CONTACT

[email protected]

00201015928694

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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