Sacubitril/Valsartan Versus Valsartan in Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881720
• Other study ID #: sacubitril/valsartan in HF
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: June 19, 2023

Study information

• Verified date: June 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 19, 2023
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Sacubitril / Valsartan Oral Tablet
Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.
• Valsartan 80 mg
group 2 received valsartan (N=40, target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Elgarbia

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Biering-Sorensen T, Lassen MCH, Shah A, Claggett B, Zile M, Pieske B, Pieske-Kraigher E, Voors A, Shi V, Lefkowitz M, Packer M, McMurray JJV, Solomon SD; PARAMOUNT Investigators. The Effect of Sacubitril/Valsartan on Left Ventricular Myocardial Deformation in Heart Failure with Preserved Ejection Fraction (PARAMOUNT trial). J Card Fail. 2023 Jun;29(6):968-973. doi: 10.1016/j.cardfail.2023.03.019. Epub 2023 Apr 7. — View Citation

Dogheim GM, Khairat I, Omran GA, El-Haggar SM, Amrawy AME, Werida RH. Clinical comparative study assessing the effect of ivabradine on neopterin and NT-Pro BNP against standard treatment in chronic heart failure patients. Eur J Clin Pharmacol. 2022 Jun;78(6):943-954. doi: 10.1007/s00228-022-03290-6. Epub 2022 Mar 3. — View Citation

McMurray JJV, Jackson AM, Lam CSP, Redfield MM, Anand IS, Ge J, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Rizkala AR, Sabarwal SV, Shah AM, Shah SJ, Shi VC, van Veldhuisen DJ, Zannad F, Zile MR, Cikes M, Goncalvesova E, Katova T, Kosztin A, Lelonek M, Sweitzer N, Vardeny O, Claggett B, Jhund PS, Solomon SD. Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF. Circulation. 2020 Feb 4;141(5):338-351. doi: 10.1161/CIRCULATIONAHA.119.044491. Epub 2019 Nov 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LVEF %	left ventricular ejection fraction percent	6 months
Primary	Lipo A (pg/ml)	Lipo protien A (pg/ml)	6 months
Primary	Troponin.I (ng/ml)	Troponin.I (ng/ml) biomarker	6 months
Primary	NT-Pro BNP	NT-pro BNP(pg/ml) biomarker	6 months
Primary	Neopterin (nmol/l)	Neopterin biomarker	6 Months