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Heart Failure With Reduced Ejection FractionPhase 4NCT05778084

Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction

A Phase 4 study testing Empagliflozin 10 MG in people with Heart Failure With Reduced Ejection Fraction, run by Alexandria University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to evaluate the relationship between NT-proBNP and empagliflozin effects in patients with chronic heart failure with mildly reduced ejection fraction (HFmrEF 41-49%) and reduced ejection fraction (HFrEF ≤40%) whether diabetic or non-diabetic patients. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Empagliflozin 10 MG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
15 Dec 2022to 15 Dec 2024
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic heart failure with mildly reduced ejection fraction (41-49%) and reduced ejection fraction (≤40%)
  • 18-70 years
  • Not receiving empagliflozin or any SGLT2 inhibitor
  • Elevated plasma NT-proBNP (≥125 pg/ml)
  • eGFR ≥ 20 ml/min/1.73m2

Who cannot join

  • Acute Coronary Syndrome (ACS)
  • Pulmonary embolism
  • Myocarditis
  • Valvular heart disease
  • Hypertrophic or restrictive cardiomyopathy
  • Congenital heart disease
Show all 22Show fewer
  • Pulmonary hypertension
  • Surgical procedures involving the heart
  • Heart contusion
  • Cardioversion, Implantable Cardioverter Defibrillator (ICD) shock
  • Patients receiving digoxin
  • Advanced age (>70years)
  • Ischemic stroke
  • Chronic Obstructive Pulmonary Disease
  • Subarachnoid haemorrhage
  • Severe infection (including pneumonia and sepsis)
  • Anemia
  • Renal dysfunction (eGFR <20ml/min/1.73m2)
  • Liver dysfunction (mainly liver cirrhosis with ascites- Child Pugh B \& C)
  • Severe burns
  • Paraneoplastic syndrome
  • Severe metabolic and hormone abnormalities (e.g thyrotoxicosis, diabetic ketosis)

Trial locations and contacts

1 site in 1 country.

Rabab Y Kosba, PharmD contact

01227609096 ext. +2

gs-rabab.kosba@alexu.edu.eg

Noha A Hamdy, PHD contact

01005182151 ext. +2

Noha.alaaeldine@alexu.edu.eg

Egypt1 site, 1 recruiting

  • Alexandria University

    Alexandria, 21521

    Noha A Hamdy, PHD, 01005182151 ext. +2, Noha.alaaeldine@alexu.edu.eg

    Hisham A Nematalla, PHD, 01220512020 ext. +2, hisham.nematalla@pharm.dmu.edu.eg

    Recruiting

Other trials in Egypt

About this study

This study aims to evaluate the relationship between NT-proBNP and empagliflozin effects in patients with chronic heart failure with mildly reduced ejection fraction (HFmrEF 41-49%) and reduced ejection fraction (HFrEF ≤40%) whether diabetic or non-diabetic patients.

Read the detailed description
  1. Ethical Committee approval has been obtained from ethics committee of Faculty of Medicine, Alexandria University.
  2. Assigning an informed consent for agreement of participation should be taken by all participants in this clinical study.
  3. Heart failure patients with reduced and mildly reduced ejection fraction will be recruited from Alexandria Main University Hospital (AMUH), private hospitals and clinics.
  4. A Blood sample will be collected from 60 patients as baseline to test for N-terminal Pro-B-type Natriuretic Peptide.
  5. The same 60 patients will take Empagliflozin for 6 months.
  6. Another blood sample will be taken from the same 60 patients to test the effect on N-terminal Pro-B-type Natriuretic Peptide after Empagliflozin administration.
  7. The appropriate statistical test will be hold according to study design and parameters to evaluate the significant results.
  8. Results conclusion discussion and recommendations will be given.
Being tested
Empagliflozin 10 MG
Keywords
Empagliflozin, Heart failure with reduced ejection fraction, Nt-proBNP

What participants receive

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

  • Empagliflozin 10 MGDrug

    Blood samples will be collected as a baseline to test for N-terminal Pro-B-type Natriuretic Peptide, followed by administration of empagliflozin for 6 months, and then another blood samples will be collected after 6 months.

Study groups in NCT05778084
Study groupRoleWhat they receive
Heart failure patients with reduced and mildly reduced ejection fractionOther* One paired test group described as Heart Failure patients with reduced and mildly reduced ejection fraction are indicated for Empagliflozin. * Blood samples will be collected as a baseline before Empagliflozin administration to test for N-terminal Pro-B-type Natriuretic Peptide, * Followed by administration of empagliflozin for 6 months. * Then retest the N-terminal Pro-B-type Natriuretic Peptide after 6 months.
Receives: Drug: Empagliflozin 10 MG

What is being measured

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

  1. NT-ProBNP

    Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months

    Measured: 6 months

Secondary outcomes (6)

  1. Hemoglobin level g/dl

    Measuring hemoglobin level at baseline and after 6 months

    Measured: 6 months

  2. Leukocytes count

    Measuring Leukocytes count at baseline and after 6 months

    Measured: 6 months

  3. Sodium level mg/dl

    Measuring serum sodium level at baseline and after 6 months

    Measured: 6 months

  4. Potassium level mg/dl

    Measuring serum potassium level at baseline and after 6 months

    Measured: 6 months

  5. Serum Creatinine

    Measuring serum creatinine level at baseline and after 6 months

    Measured: 6 months

  6. Ejection Fraction

    Measuring Ejection Fraction at baseline and after 6 months

    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 posted21 Mar 2023
  2. Study start15 Dec 2022
  3. Primary completion15 Jun 2024 (estimated)
  4. Study completion15 Dec 2024 (estimated)

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
Not applicable
Intervention model
Single group
Model description
Open labelled interventional study
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05778084
Sponsor's protocol ID
0107427
Status last verified
Oct 2022
First submitted
9 Mar 2023
Last updated
21 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin 10 MG in people with Heart Failure With Reduced Ejection Fraction, run by Alexandria 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 5 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 21 Mar 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?

Results are not available in the source record.

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

Contact Rabab Y Kosba, PharmD (01227609096 ext. +2, gs-rabab.kosba@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NT-ProBNP (time frame: 6 months). 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 NCT05778084.

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 21 Mar 2023.

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