Sacubitril/Valsartan Versus Valsartan in Heart Failure

NCT05881720 | Completed Phase 4

• 1 other identifier: sacubitril/valsartan in HF
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

LVEF%,; Lipo A,; troponin I,; NT-Pro BNP,; neopterin

Outcome Measures

Primary Outcomes (5)

• LVEF %

  left ventricular ejection fraction percent

  6 months

• Lipo A (pg/ml)

  Lipo protien A (pg/ml)

  6 months

• Troponin.I (ng/ml)

  Troponin.I (ng/ml) biomarker

  6 months

• NT-Pro BNP

  NT-pro BNP(pg/ml) biomarker

  6 months

• Neopterin (nmol/l)

  Neopterin biomarker

  6 Months

Study Arms (2)

Group 1 (N = 40)

EXPERIMENTAL

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

Drug: Sacubitril / Valsartan Oral Tablet

Group 2 (N = 40)

EXPERIMENTAL

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

Drug: Valsartan 80 mg

Interventions

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.

Also known as: sacubitril / valsartan (100 mg twice daily)

Group 1 (N = 40)

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.

Also known as: Valsartan

Group 2 (N = 40)

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University Hospital

Tanta, Elgarbia, 31527, Egypt

Location

Related Publications (3)

• 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.

  PMID: 35238960 BACKGROUND

• 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.

  PMID: 31736337 BACKGROUND

• 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.

  PMID: 37031887 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination; sacubitril; Valsartan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Rehab H Werida, Ass.Prof.

  Damanhour University

  STUDY CHAIR

• Ahmed El-Sherbeni

  Tanta University

  STUDY DIRECTOR

• Lamiaa Khedr

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 31, 2023
• Study Start: January 1, 2022
• Primary Completion: June 18, 2023
• Study Completion: June 19, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)