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Completed

NCT Number: NCT05881720

Sacubitril/Valsartan Versus Valsartan in Heart Failure

The objective of this study was to identify potential prognostic factors of sacubitril/valsartan vs Valsartan treatment response.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University Hospital

Tanta, Elgarbia, 31527, Egypt

About this study

Study will include 80 symptomatic patients with chronic HFrEF (left ventricular ejection fraction ≤35%) and New York Heart Association (NYHA) class II/III: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment. Analysis of biochemical parameters, cardiopulmonary exercise testing, and echocardiographic evaluation was performed at baseline and 6 months later. The primary outcome was the change in LVEF%, Lipo A, troponin I, NT-Pro BNP and neopterin levels. The secondary outcome is reporting efficacy and safety of sacubitril/valsartan vs Valsartan use and the relationship between NYHA and EF and biomarkers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with HF were enrolled if aged > 35 years,
  • Stable symptomatic systolic chronic HF (≥ 4 weeks), with left ventricular ejection fraction (LVEF) < 35%,
  • NYHA class II-III,
  • Sinus rhythm and resting HR ≥ 70 beats/min on optimised standard medical therapy.

Exclusion criteria

  • Patients with acute decompensation,
  • Cerebrovascular events during the previous 6 months,
  • Pregnancy, breastfeeding,
  • Any valve dysfunction/abnormality,
  • Active myocarditis,
  • Second-degree and third-degree atrioventricular block,
  • Sick sinus syndrome.

Treatment and study plan

Sacubitril / Valsartan Oral Tablet

Drug

Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.

Other names: sacubitril / valsartan (100 mg twice daily)

Valsartan 80 mg

Drug

group 2 received valsartan (N=40, target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.

Other names: Valsartan

Primary outcomes

  1. LVEF %

    Time frame: 6 months

    left ventricular ejection fraction percent

  2. Lipo A (pg/ml)

    Time frame: 6 months

    Lipo protien A (pg/ml)

  3. Troponin.I (ng/ml)

    Time frame: 6 months

    Troponin.I (ng/ml) biomarker

  4. NT-Pro BNP

    Time frame: 6 months

    NT-pro BNP(pg/ml) biomarker

  5. Neopterin (nmol/l)

    Time frame: 6 Months

    Neopterin biomarker

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Tanta University

Registry information

Official study title

Effect of Sacubitril/Valsartan Versus Valsartan on Left Ventricular Ejection Fraction and Biomarker in Heart Failure

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 31, 2023
Registry last updated
Jun 27, 2023

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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