Sacubitril/Valsartan Versus Valsartan in Heart Failure

June 25, 2023 updated by: Rehab Werida, Damanhour University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elgarbia
      • Tanta, Elgarbia, Egypt, 31527
        • tanta University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (N = 40)
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 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)
Experimental: Group 2 (N = 40)
group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Drug: 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.
Other Names:
  • Valsartan

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Collaborators

Tanta University

Investigators

  • Study Chair: Rehab H Werida, Ass.Prof., Damanhour University
  • Study Director: Ahmed El-Sherbeni, Tanta University
  • Principal Investigator: Lamiaa Khedr, Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 18, 2023

Study Completion (Actual)

June 19, 2023

Study Registration Dates

First Submitted

May 21, 2023

First Submitted That Met QC Criteria

May 21, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 25, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sacubitril/valsartan in HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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