Hematocrit ChangeNCT06284850
Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels
An observational study of Hematocrit Change and Cardiovascular Prevention, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematocrit Change, Cardiovascular Prevention, Empagliflozin
- What is being tested?
- Empagliflozin10Mg Tab
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 30 Nov 2023to Nov 2025
- Phase
- Observational
- 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
Study population: Patients>18 year-old and at least one of the following * Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c <6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA * Heart Failure defined as Ejection Fraction<40% or NT-proBNP>300pg/ml or Atrial fibrillation and NT-proBNP>900pg/ml * Chronic Kidney Disease defined as eGFR<60ml/min/1.73m2 (CKPD- EPI) or/and UACR>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment
Who may be able to join
- Patients>18 year-old and at least one of the following
- Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c <6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA
- Heart Failure defined as Ejection Fraction<40% or NT-proBNP>300pg/ml or Atrial fibrillation and NT-proBNP>900pg/ml
- Chronic Kidney Disease defined as eGFR<60ml/min/1.73m2 (CKPD- EPI) or/and UACR>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment
Who cannot join
- Patients already treated with an SGLT-2 inhibitor
- Patients with Hb<11gr/dl or>16gr/dl
- Patients with history of inherited or acquired hemoglobin disease
- Patients with history of hemolytic anemia
- Patients with history of hematologic malignancy or myelodysplastic syndrome or myeloproliferative syndrome
- Patients treated within the last 6 months for anemia due to iron, B12 or folate deficiency
Show all 12Show fewer
- Patients with history of major hemorrhage or major operation leading to RBC transfusion within the last 3 months.
- Patients planning major operation or revascularization procedure within the 12 following weeks
- Patients treated with erythropoietin
- Patients with Chronic Kidney Disease and GFR<30ml/min/1.73m2
- Pregnancy
- Women of childbearing age not receiving appropriate contraception measures
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Papageorgiou General Hospital
Thessaloniki, Central Macedonia, 56403
KONSTANTINOS KITSIOS, MD,MSc,PhD, +306977295744, kitsios_k@yahoo.gr
About this study
Official title: Red Blood Cell 2,3-biphosphoglycerate Levels in Patients Treated With Empagliflozin. A Prospective Cohort Study.
The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors.
- Conditions
- Hematocrit Change, Cardiovascular Prevention, Empagliflozin, SGLT2-Inhibitors, Tissue Oxygenation
- Being tested
- Empagliflozin10Mg Tab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin10Mg TabDrug
Also called JARDIANCE 10MG
TB JARDIANCE 10MG
| Study group | Role | What they receive |
|---|---|---|
| treatment with empagliflozin 10mg od | empagliflozin 10mg OD Receives: Drug: Empagliflozin10Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
Measured: 12 weeks
Secondary outcomes (8)
Mean change in Hct (%)
Mean change in Hct(%)
Measured: 12 weeks
Hb (mg/dl)
Mean change in Hb (mg/dl)
Measured: 12 weeks
RBC (x1000000/μl)
Mean change in RBC (x1000000/μl)
Measured: 12 weeks
MCV (fl),
Mean change in MCV (fl)
Measured: 12 weeks
HbA1c (%, mmol/mol),
Mean change inHbA1c (%, mmol/mol)
Measured: 12 weeks
erythropoietin (mU/ml)
Mean change in erythropoietin (mU/ml)
Measured: 12 weeks
eGFR (ml/min/1.73m2),
Mean change in eGFR (ml/min/1.73m2),
Measured: 12 weeks
Urine Albumin to Creatinine Ratio (mg/g)
Mean change in Urine Albumin to Creatinine Ratio (mg/g)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start30 Nov 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematocrit ChangeStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Trakatelli, Aristotle University Of Thessaloniki
- Investigators
- KONSTANTINOS KITSIOS, MD,MSc,PhD, Principal investigator, Aristotle University of Thessaloniki 3d Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284850
- Sponsor's protocol ID
- Christina Trakatelli
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: concerns about personal data safety
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell 2,3-biphosphoglycerate Levels in Patients Treated With Empagliflozin. A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06284850
- Acronym / sponsor ID
- Christina Trakatelli
- Conditions
- Hematocrit Change, Cardiovascular Prevention, Empagliflozin, SGLT2-Inhibitors, Tissue Oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 29 Feb 2024 (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 investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment with empagliflozin 10mg od | – | Drug: Empagliflozin10Mg Tabempagliflozin 10mg OD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients>18 year-old and at least one of the following * Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c <6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA * Heart Failure defined as Ejection Fraction<40% or NT-proBNP>300pg/ml or Atrial fibrillation and NT-proBNP>900pg/ml * Chronic Kidney Disease defined as eGFR<60ml/min/1.73m2 (CKPD- EPI) or/and UACR>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment
Key inclusion criteria (4 listed)
- Patients>18 year-old and at least one of the following
- Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c <6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA
- Heart Failure defined as Ejection Fraction<40% or NT-proBNP>300pg/ml or Atrial fibrillation and NT-proBNP>900pg/ml
- Chronic Kidney Disease defined as eGFR<60ml/min/1.73m2 (CKPD- EPI) or/and UACR>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment
Key exclusion criteria (12 listed)
- Patients already treated with an SGLT-2 inhibitor
- Patients with Hb<11gr/dl or>16gr/dl
- Patients with history of inherited or acquired hemoglobin disease
- Patients with history of hemolytic anemia
- Patients with history of hematologic malignancy or myelodysplastic syndrome or myeloproliferative syndrome
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 |
|---|---|---|
| Empagliflozin10Mg TabAlso: JARDIANCE 10MGTB JARDIANCE 10MG | Drug | treatment with empagliflozin 10mg od |
Primary outcome
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
Time frame: 12 weeks
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
8 secondary outcomes
Mean change in Hct (%)
Time frame: 12 weeks
Hb (mg/dl)
Time frame: 12 weeks
RBC (x1000000/μl)
Time frame: 12 weeks
MCV (fl),
Time frame: 12 weeks
HbA1c (%, mmol/mol),
Time frame: 12 weeks
erythropoietin (mU/ml)
Time frame: 12 weeks
eGFR (ml/min/1.73m2),
Time frame: 12 weeks
Urine Albumin to Creatinine Ratio (mg/g)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: Undecided. concerns about personal data safety
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.
KONSTANTINOS KITSIOS, MD,MSc,PhD principal investigator
Aristotle University of Thessaloniki 3d Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematocrit Change and Cardiovascular Prevention, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 12 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 29 Feb 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KONSTANTINOS KITSIOS, MD,MSc,PhD (+306977295744, kitsios_k@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml) (time frame: 12 weeks). 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 29 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.