Clinical trial NCT05881720: Sacubitril/Valsartan Versus Valsartan in Heart Failure
Official title: Effect of Sacubitril/Valsartan Versus Valsartan on Left Ventricular Ejection Fraction and Biomarker in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: LVEF%,
Lipo A,
troponin I,
NT-Pro BNP,
neopterin
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2023-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: LVEF %
timeFrame: 6 months
measure: Lipo A (pg/ml)
timeFrame: 6 months
measure: Troponin.I (ng/ml)
timeFrame: 6 months
measure: NT-Pro BNP
timeFrame: 6 months
measure: Neopterin (nmol/l)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Elgarbia
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass.Prof.
role: STUDY_CHAIR
affiliation: Tanta University
name: Ahmed El-Sherbeni
role: STUDY_DIRECTOR
affiliation: Tanta University
name: Lamiaa Khedr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.