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Sacubitril/Valsartan Versus Valsartan in Heart Failure

Sponsor
Damanhour University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05881720
Collaborator
Tanta University (Other)
80
Enrollment
1
Location
2
Arms
8.7
Anticipated Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Sacubitril / Valsartan Oral Tablet
  • Drug: Valsartan 160mg
 Phase 4

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, 200 mg twice daily) or group 2 received valsartan (target dose, 160 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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group 1 (N = 40) received sacubitril/valsartan (target dose, 200 mg twice daily) or group 2 received valsartan (target dose, 160 mg twice daily) in addition to recommended therapy according to physician's judgment.Group 1 (N = 40) received sacubitril/valsartan (target dose, 200 mg twice daily) or group 2 received valsartan (target dose, 160 mg twice daily) in addition to recommended therapy according to physician's judgment.
Masking:
Double (Participant, Investigator)
Masking Description:
Double Blind randomized controlled trial
Primary Purpose:
Treatment
Official Title:
Effect of Sacubitril/Valsartan Versus Valsartan on Left Ventricular Ejection Fraction and Biomarker in Heart Failure
Actual Study Start Date :
Apr 10, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1 (N = 40)

Group 1 (N = 40) received sacubitril/valsartan (target dose, 200 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, 200 mg twice daily) in addition to recommended therapy according to physician's judgment.
Other Names:
  • sacubitril / valsartan (200 mg twice daily)

    		•
    Experimental: Group 2 (N = 40)

    group 2 received valsartan (target dose, 160 mg twice daily) in addition to recommended therapy according to physician's judgment.

    Drug: Valsartan 160mg
    group 2 received valsartan (N=40, target dose, 160 mg twice daily) in addition to recommended therapy according to physician's judgment.
    Other Names:
  • Valsartan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. LVEF % [6 months]

      left ventricular ejection fraction percent

    2. Lipo A (pg/ml) [6 months]

      Lipo protien A (pg/ml)

    3. Troponin.I (ng/ml) [6 months]

      Troponin.I (ng/ml) biomarker

    4. NT-Pro BNP [6 months]

      NT-pro BNP(pg/ml) biomarker

    5. Neopterin (nmol/l) [6 Months]

      Neopterin biomarker

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Hospital Tanta Elgarbia Egypt 31527

    Sponsors and Collaborators

    • Damanhour University
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rehab Werida, Associate Professor, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT05881720
    Other Study ID Numbers:
    • sacubitril/valsartan in HF
    First Posted:
    May 31, 2023
    Last Update Posted:
    Jun 1, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rehab Werida, Associate Professor, Damanhour University
    LVEF%,
    Lipo A,
    troponin I,
    NT-Pro BNP,
    neopterin
    Additional relevant MeSH terms:
    Heart Failure
    Valsartan
    Sacubitril and valsartan sodium hydrate drug combination

    Study Results

    No Results Posted as of Jun 1, 2023