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Sacubitril/Valsartan Versus Valsartan in Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Sacubitril / Valsartan Oral Tablet
Valsartan 80 mg
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring LVEF%,, Lipo A,, troponin I,, NT-Pro BNP,, neopterin

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanta University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 (N = 40)

Group 2 (N = 40)

Arm Description

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

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

Outcomes

Primary Outcome Measures

LVEF %
left ventricular ejection fraction percent
Lipo A (pg/ml)
Lipo protien A (pg/ml)
Troponin.I (ng/ml)
Troponin.I (ng/ml) biomarker
NT-Pro BNP
NT-pro BNP(pg/ml) biomarker
Neopterin (nmol/l)
Neopterin biomarker

Secondary Outcome Measures

Full Information

First Posted
May 21, 2023
Last Updated
June 25, 2023
Sponsor
Damanhour University
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05881720
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 18, 2023 (Actual)
Study Completion Date
June 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Damanhour University
Collaborators
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
LVEF%,, Lipo A,, troponin I,, NT-Pro BNP,, neopterin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Double Blind randomized controlled trial
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (N = 40)
Arm Type
Experimental
Arm Description
Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.
Arm Title
Group 2 (N = 40)
Arm Type
Experimental
Arm Description
group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Intervention Type
Drug
Intervention Name(s)
Sacubitril / Valsartan Oral Tablet
Other Intervention Name(s)
sacubitril / valsartan (100 mg twice daily)
Intervention Description
Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.
Intervention Type
Drug
Intervention Name(s)
Valsartan 80 mg
Other Intervention Name(s)
Valsartan
Intervention Description
group 2 received valsartan (N=40, target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Primary Outcome Measure Information:
Title
LVEF %
Description
left ventricular ejection fraction percent
Time Frame
6 months
Title
Lipo A (pg/ml)
Description
Lipo protien A (pg/ml)
Time Frame
6 months
Title
Troponin.I (ng/ml)
Description
Troponin.I (ng/ml) biomarker
Time Frame
6 months
Title
NT-Pro BNP
Description
NT-pro BNP(pg/ml) biomarker
Time Frame
6 months
Title
Neopterin (nmol/l)
Description
Neopterin biomarker
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab H Werida, Ass.Prof.
Organizational Affiliation
Damanhour University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed El-Sherbeni
Organizational Affiliation
Tanta University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lamiaa Khedr
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
Elgarbia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35238960
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.
Results Reference
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PubMed Identifier
31736337
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.
Results Reference
background
PubMed Identifier
37031887
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.
Results Reference
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Sacubitril/Valsartan Versus Valsartan in Heart Failure

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