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Heart FailurePhase 4NCT05881720

Sacubitril/Valsartan Versus Valsartan in Heart Failure

A Phase 4 study testing Sacubitril / Valsartan Oral Tablet and Valsartan 80 mg in people with Heart Failure, run by Damanhour University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
Sacubitril / Valsartan Oral Tablet and Valsartan 80 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
1 Jan 2022to 19 Jun 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Tanta University Hospital

    Tanta, Elgarbia, 31527

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Conditions
Heart Failure
Being tested
Sacubitril / Valsartan Oral Tablet, Valsartan 80 mg
Keywords
LVEF%,, Lipo A,, troponin I,, NT-Pro BNP,, neopterin
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacubitril / Valsartan Oral TabletDrug

    Also called sacubitril / valsartan (100 mg twice daily)

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

  • Valsartan 80 mgDrug

    Also called Valsartan

    group 2 received valsartan (N=40, target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.

Study groups in NCT05881720
Study groupRoleWhat they receive
Group 1 (N = 40)ExperimentalGroup 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.
Receives: Drug: Sacubitril / Valsartan Oral Tablet
Group 2 (N = 40)Experimentalgroup 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Receives: Drug: Valsartan 80 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LVEF %

    left ventricular ejection fraction percent

    Measured: 6 months

  2. Lipo A (pg/ml)

    Lipo protien A (pg/ml)

    Measured: 6 months

  3. Troponin.I (ng/ml)

    Troponin.I (ng/ml) biomarker

    Measured: 6 months

  4. NT-Pro BNP

    NT-pro BNP(pg/ml) biomarker

    Measured: 6 months

  5. Neopterin (nmol/l)

    Neopterin biomarker

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start1 Jan 2022
  3. Primary completion18 Jun 2023
  4. Study completion19 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05881720
Sponsor's protocol ID
sacubitril/valsartan in HF
Status last verified
Jun 2023
First submitted
21 May 2023
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35238960

  • 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.

    PubMed 31736337

  • 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.

    PubMed 37031887

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sacubitril / Valsartan Oral Tablet and Valsartan 80 mg in people with Heart Failure, run by Damanhour University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LVEF % (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05881720, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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