Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate L... | NCT06284850

Studies
Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

NCT06284850

Sponsor

Aristotle University Of Thessaloniki

Status

Unknown status

Last Update Posted

Feb 29, 2024Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Hematocrit Change
Cardiovascular Prevention
Empagliflozin
SGLT2-Inhibitors
Tissue Oxygenation

Interventions

Empagliflozin10Mg Tab

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2023Actual

Primary Completion Date

Nov 2025Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Jan 10, 2024

First Submission Date that Met QC Criteria

Feb 27, 2024

First Posted Date

Feb 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2024

Last Update Posted Date

Feb 29, 2024Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
treatment with empagliflozin 10mg od		empagliflozin 10mg OD	Drug: Empagliflozin10Mg Tab

Name	Type	Description	Arm Group Labels	Other Names
Empagliflozin10Mg Tab	Drug	TB JARDIANCE 10MG	treatment with empagliflozin 10mg od

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)	Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean change in Hct (%)	Mean change in Hct(%)	12 weeks
Hb (mg/dl)	Mean change in Hb (mg/dl)	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
KONSTANTINOS KITSIOS, MD,MSc,PhD	Contact	+306977295744		kitsios_k@yahoo.gr

Overall Officials

Name	Affiliation	Role
KONSTANTINOS KITSIOS, MD,MSc,PhD	Aristotle University of Thessaloniki 3d Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Papageorgiou General Hospital	Recruiting	Thessaloniki	Central Macedonia	56403	Greece