Heart FailureNCT06065280
Sodium-glucose Transport 2 Inhibitors (SGLT2i) in HFrEF Patients
A study testing Empagliflozin 10 MG and Dapagliflozin 10 MG in people with Heart Failure and Reduced Ejection Fraction Heart Failure, run by Damanhour University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the efficacy, safety and cardiovascular outcomes of Sodium-glucose transport protein 2 inhibitors (SGLT2i) therapy in patients with heart failure reduced ejection fraction ( HFrEF) with and without diabetes mellitus and is to evaluate short-term effect of these drugs using the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Reduced Ejection Fraction Heart Failure
- What is being tested?
- Empagliflozin 10 MG and Dapagliflozin 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Dec 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HFrEF, on optimal medical therapy according to European Society of Cardiology guidelines,
- an age of at least 18 years,
- an ejection fraction of 40% or less, with New York Heart Association (NYHA) class II - IV symptoms will be eligible for the study.
Who cannot join
- Recent treatment with or unacceptable side effects associated with an SGLT2i
- Type-I diabetes mellitus,
- Symptoms of hypotension or a systolic blood pressure of less than 95 mm Hg,
- Severe CKD and an estimated glomerular filtration rate (eGFR) below 30 ml per minute per 1.73 m2 of body-surface area or rapidly declining renal function
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
Damanhūr, Elbehairah, 31527
About this study
Official title: Sodium-glucose Transport 2 Inhibitors (SGLT2i) in Heart Failure Reduced Ejection Fraction (HFrEF) Patients
The aim of this study is to assess the efficacy, safety and cardiovascular outcomes of Sodium-glucose transport protein 2 inhibitors (SGLT2i) therapy in patients with heart failure reduced ejection fraction ( HFrEF) with and without diabetes mellitus and is to evaluate short-term effect of these drugs using the cardiac biomarkers Neopterin.
Read the detailed description
- A 3 months, prospective interventional study, which will include 80 patients with established heart failure reduced ejection fraction on optimal standard medical therapy, who will be consecutively randomly allocated to the SGLT2i (10 mg once a day Empagliflozin or Dapagliflozin ) with 40 patients with diabetes mellitus group and 40 patients non-diabetes mellitus group. (Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin )
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
All patients will undergo :
- Provided written informed consent and entered a 10-day screening period, during which the trial inclusion and exclusion criteria were checked and baseline information gathered.
- Complete history with NYHA class assessment and clinical examination before and after the study
- 12-lead ECG before and after the study
- Complete Echocardiography study before and after the study
- Baseline venous sampling for urea, creatinine, potassium ,CBC , fasting blood sugar and Hemoglobin A1C at the beginning of the study and after 3 months of the study
- Measurements of Neopterin by ELISA at the beginning of the of the study and after 3 months of the study
Outcomes :
- Clinical outcomes, all patients will be followed up for 3 months for:
- 1ry outcomes: A)Complete Echocardiography monitoring for improvements B) Level of Neopterin C)will be a composite of worsening heart failure requiring hospitalization and/ or death from cardiovascular causes.
- 2ry outcomes: A) will be the additional secondary outcomes were the total number of hospitalizations for heart failure B) functional capacity and quality of life by the Kansas City Cardiomyopathy Questionnaire (KCCQ) reflects key health status.
- a composite of worsening renal function, which will defined as a sustained decline in the eGFR of 50% or greater, end-stage renal disease (defined as a sustained [≥28 days] eGFR of <15 ml per minute per 1.73 m2, sustained dialysis, or renal transplantation), or renal death; and death from any cause.
- Safety outcomes : included serious adverse events, adverse events associated with the discontinuation of a trial treatment, adverse events of interest (i.e., volume depletion, renal events, major hypoglycemic events, diabetic ketoacidosis, dizziness , syncope ,acute renal failure or dialysis and laboratory findings of note, hypoglycemia and hypokalemia
- Being tested
- Empagliflozin 10 MG, Dapagliflozin 10 MG
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Jardiance 10 mg
Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.
Dapagliflozin 10 MGDrug
Also called Forxiga 10 mg
Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic/HFrEF Group | Experimental | 40 patients with diabetes mellitus patients will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin. Receives: Drug: Empagliflozin 10 MG; Drug: Dapagliflozin 10 MG |
| Nondiabetic/HFrEF Group | Experimental | 40 patients non-diabetes mellitus group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin. Receives: Drug: Empagliflozin 10 MG; Drug: Dapagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neopterin Concentration
Neopterin serum level pg/ml
Measured: 3 month
Secondary outcomes (1)
hospitalization rate
hospitalizations duration (days)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Nov 2022
- Primary completion1 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 80 patients with established heart failure reduced ejection fraction on optimal standard medical therapy, who will be consecutively randomly allocated to the SGLT2i (10 mg once a day Empagliflozin or Dapagliflozin ) with 40 patients with diabetes mellitus group and 40 patients non-diabetes mellitus group. (Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin )
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass Prof., Study chair, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065280
- Sponsor's protocol ID
- SGLT2i in Heart Failure
- Status last verified
- Feb 2025
- First submitted
- 27 Sep 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium-glucose Transport 2 Inhibitors (SGLT2i) in Heart Failure Reduced Ejection Fraction (HFrEF) Patients
- ClinicalTrials.gov ID
- NCT06065280
- Acronym / sponsor ID
- SGLT2i in Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the efficacy, safety and cardiovascular outcomes of Sodium-glucose transport protein 2 inhibitors (SGLT2i) therapy in patients with heart failure reduced ejection fraction ( HFrEF) with and without diabetes mellitus and is to evaluate short-term effect of these drugs using the cardiac biomarkers Neopterin.
Detailed description
- A 3 months, prospective interventional study, which will include 80 patients with established heart failure reduced ejection fraction on optimal standard medical therapy, who will be consecutively randomly allocated to the SGLT2i (10 mg once a day Empagliflozin or Dapagliflozin ) with 40 patients with diabetes mellitus group and 40 patients non-diabetes mellitus group. (Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin )
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
All patients will undergo :
- Provided written informed consent and entered a 10-day screening period, during which the trial inclusion and exclusion criteria were checked and baseline information gathered.
- Complete history with NYHA class assessment and clinical examination before and after the study
- 12-lead ECG before and after the study
- Complete Echocardiography study before and after the study
- Baseline venous sampling for urea, creatinine, potassium ,CBC , fasting blood sugar and Hemoglobin A1C at the beginning of the study and after 3 months of the study
- Measurements of Neopterin by ELISA at the beginning of the of the study and after 3 months of the study
Outcomes :
- Clinical outcomes, all patients will be followed up for 3 months for:
- 1ry outcomes: A)Complete Echocardiography monitoring for improvements B) Level of Neopterin C)will be a composite of worsening heart failure requiring hospitalization and/ or death from cardiovascular causes.
- 2ry outcomes: A) will be the additional secondary outcomes were the total number of hospitalizations for heart failure B) functional capacity and quality of life by the Kansas City Cardiomyopathy Questionnaire (KCCQ) reflects key health status.
- a composite of worsening renal function, which will defined as a sustained decline in the eGFR of 50% or greater, end-stage renal disease (defined as a sustained [≥28 days] eGFR of <15 ml per minute per 1.73 m2, sustained dialysis, or renal transplantation), or renal death; and death from any cause.
- Safety outcomes : included serious adverse events, adverse events associated with the discontinuation of a trial treatment, adverse events of interest (i.e., volume depletion, renal events, major hypoglycemic events, diabetic ketoacidosis, dizziness , syncope ,acute renal failure or dialysis and laboratory findings of note, hypoglycemia and hypokalemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 80 patients with established heart failure reduced ejection fraction on optimal standard medical therapy, who will be consecutively randomly allocated to the SGLT2i (10 mg once a day Empagliflozin or Dapagliflozin ) with 40 patients with diabetes mellitus group and 40 patients non-diabetes mellitus group. (Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin )
| Arm | Type | Receives |
|---|---|---|
| Diabetic/HFrEF Group | Experimental | Drug: Empagliflozin 10 MG, Drug: Dapagliflozin 10 MG40 patients with diabetes mellitus patients will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin. |
| Nondiabetic/HFrEF Group | Experimental | Drug: Empagliflozin 10 MG, Drug: Dapagliflozin 10 MG40 patients non-diabetes mellitus group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with HFrEF, on optimal medical therapy according to European Society of Cardiology guidelines,
- an age of at least 18 years,
- an ejection fraction of 40% or less, with New York Heart Association (NYHA) class II - IV symptoms will be eligible for the study.
Key exclusion criteria (5 listed)
- Recent treatment with or unacceptable side effects associated with an SGLT2i
- Type-I diabetes mellitus,
- Symptoms of hypotension or a systolic blood pressure of less than 95 mm Hg,
- Severe CKD and an estimated glomerular filtration rate (eGFR) below 30 ml per minute per 1.73 m2 of body-surface area or rapidly declining renal function
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGAlso: Jardiance 10 mgEach group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily. | Drug | Diabetic/HFrEF Group, Nondiabetic/HFrEF Group |
| Dapagliflozin 10 MGAlso: Forxiga 10 mgEach group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily. | Drug | Diabetic/HFrEF Group, Nondiabetic/HFrEF Group |
Primary outcome
Neopterin Concentration
Time frame: 3 month
Neopterin serum level pg/ml
1 secondary outcome
hospitalization rate
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rehab H Werida, Ass Prof. study chair
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin 10 MG and Dapagliflozin 10 MG in people with Heart Failure and Reduced Ejection Fraction 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 3 inclusion and 5 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 4 Feb 2025. 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.
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?
Neopterin Concentration (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.