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Heart Failure With Reduced Ejection FractionPhase 4HFrEFNCT06632561

Benefits of Empagliflozin in Patients With Heart Failure and Reduced Ejection Fraction Without Diabetes Mellitus

A Phase 4 study testing Empagliflozin 10 mg in people with Heart Failure With Reduced Ejection Fraction, run by Ashraf Wasfy Beshay Aziz 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 study is a short to mid-term randomized single-blind placebo controlled study that aimed to detect the effects of empagliflozin (a sodium-glucose cotransporter-2 inhibitor) compared to placebo on LV end-diastolic and end-systolic volumes, LV ejection fraction, N-terminal pro-B-type natriuretic peptide (NT-proBNP)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Empagliflozin 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
1 siteEgypt
Study dates
26 Jul 2021to 14 Mar 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ambulatory non-diabetic adult male and non-pregnant female patients with established diagnosis of heart failure (HF) New York Heart Association functional class II-IV and left ventricular ejection fraction (LVEF) ≤ 40% (calculated by echocardiography within the previous 6 months before randomization).
  • Patients should have stable symptoms and stable guideline-directed medical therapy for HF within the last 3 months before randomization. It was mandatory that all patients have reached the maximum tolerated doses of guideline-directed medical therapy for HF and are regular on them for at least 3 months before participation.
  • Patients were not known to be diabetic and have no history of diabetes remission and their baseline glycosylated hemoglobin (HbA1c) should have been < 5.7%.
  • Patients have never been on SGLT2 inhibitor therapy before.
  • Estimated glomerular filtration rate (eGFR) should have been ≥ 45 mL/min/1.73 m² using the chronic kidney disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2009)

Who cannot join

  • Women who were pregnant at time of selection, possibly pregnant, breast-feeding, or planning to become pregnant during the study period.
  • Patients who had acute coronary syndrome, cardiac surgery, stroke or transient ischemic attack (TIA) within the last 3 months before randomization.
  • Patients who had infiltrative cardiomyopathy, muscular dystrophies, hypertrophic cardiomyopathy, peripartum cardiomyopathy, pericardial restriction or chemotherapy induced cardiomyopathy within 12 months before randomization.
  • Patients with severe valvular heart disease.
  • Patients who had acute decompensated HF or were on continuous parenteral inotropic agents with 3 months before randomization.
  • Patients who had cardiac resynchronization therapy (CRT) implantation within 3 months before randomization.
  • History of recurrent urinary tract infection, cancer or any life threatening condition or psychiatric disease incompatible with being in the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Beni-Suef University

    BeniSuef, 62521

Other trials in Egypt

About this study

The study is a short to mid-term randomized single-blind placebo controlled study that aimed to detect the effects of empagliflozin (a sodium-glucose cotransporter-2 inhibitor) compared to placebo on LV end-diastolic and end-systolic volumes, LV ejection fraction, N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity and quality of life (QoL) among non-diabetic patients with HFrEF.

Being tested
Empagliflozin 10 mg, Placebo

What participants receive

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

  • Empagliflozin 10 mgDrug

    Empagliflozin (a sodium-glucose cotransporter-2 inhibitor) 10 mg one tablet daily dose for 6 months

  • PlaceboDrug

    Sugar pills one tablet daily for 6 months

Study groups in NCT06632561
Study groupRoleWhat they receive
Empagliflozin armExperimental37 patients received Empagliflozin 10 mg/day in addition to their guideline-directed medical therapy for HF
Receives: Drug: Empagliflozin 10 mg
Placebo armPlacebo comparator37 patients received placebo in addition to their guideline-directed medical therapy for HF
Receives: Drug: Placebo

What is being measured

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

  1. The changes in LV volumes (mL)

    To measure the changes in of Left Ventricular end-diastolic volume (LVEDV) (mL) and Left Ventricular end-systolic volume (LVESV) (mL) via transthoracic echocardiography using the modified Simpson's rule (the biplane disk summation approach).

    Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.

    Measured: From enrollment to the end of treatment at 6 months

  2. The changes in of Left Ventricular Ejection Fraction (LVEF) (%)

    To measure the changes in of Left Ventricular Ejection Fraction (LVEF) (%) via transthoracic echocardiography using the modified Simpson's rule (the biplane disk summation approach).

    Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.

    Measured: From enrollment to the end of treatment at 6 months

Secondary outcomes (3)

  1. The changes in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL)

    Measurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL) at baseline and at the end of treatment phase after 6 months within both study arms via the electrochemiluminescence immunoassay "ECLIA".

    Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.

    Measured: From enrollment to the end of treatment at 6 months

  2. The changes in 6 minute walk test (meters)

    Measurement of 6 minute walk test (meters) at baseline and at the end of treatment phase after 6 months within both study arms.

    Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.

    Measured: From enrollment to the end of treatment at 6 months

  3. The changes in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points)

    Measurement of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points) at baseline and at the end of treatment phase after 6 months within both study arms.

    Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.

    Measured: From enrollment to the end of treatment at 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 posted9 Oct 2024
  2. Study start26 Jul 2021
  3. Primary completion9 Mar 2022
  4. Study completion14 Mar 2022

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
Masking
Single blind
Who is masked
Participant
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06632561
Sponsor's protocol ID
FMBSUREC/06072021/Aziz
Acronym
HFrEF
Status last verified
Oct 2024
First submitted
6 Oct 2024
Last updated
9 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Santos-Gallego CG, Vargas-Delgado AP, Requena-Ibanez JA, Garcia-Ropero A, Mancini D, Pinney S, Macaluso F, Sartori S, Roque M, Sabatel-Perez F, Rodriguez-Cordero A, Zafar MU, Fergus I, Atallah-Lajam F, Contreras JP, Varley C, Moreno PR, Abascal VM, Lala A, Tamler R, Sanz J, Fuster V, Badimon JJ; EMPA-TROPISM (ATRU-4) Investigators. Randomized Trial of Empagliflozin in Nondiabetic Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2021 Jan 26;77(3):243-255. doi: 10.1016/j.jacc.2020.11.008. Epub 2020 Nov 13.

    PubMed 33197559

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 Ashraf Wasfy Beshay Aziz 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 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 9 Oct 2024. 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. Some participants in this study may receive a placebo. 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?

The changes in LV volumes (mL) (time frame: From enrollment to the end of treatment at 6 months). The study lists 2 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 NCT06632561, which also lists 1 linked publication.

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 9 Oct 2024.

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