NCT07478575

Brief Summary

This retrospective cohort study investigates the effects of SGLT2 inhibitor therapy on erythropoiesis and its association with cardiac and renal outcomes in patients with chronic heart failure. The study will compare hematological parameters, echocardiographic measures, and clinical outcomes between patients who initiated SGLT2 inhibitor therapy and a matched control group receiving guideline-directed medical therapy alone over a 12-month follow-up period.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jan 2019Dec 2026

Study Start

First participant enrolled

January 1, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

March 12, 2026

Last Update Submit

March 12, 2026

Conditions

Heart FailureAnemiaRenal Insufficiency

Keywords

SGLT2 inhibitorsHeart FailureErythropoiesisAnemia

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin levels

    Change in hemoglobin (g/L)

    Baseline to 12 months

Secondary Outcomes (6)

  • Change in left ventricular ejection fraction

    Baseline to 12 months

  • Change in left ventricular end-diastolic volume

    Baseline to 12 months

  • Change in left ventricular end-systolic volume

    Baseline to 12 months

  • Change in N-terminal pro-B-type natriuretic peptide levels

    Baseline to 12 months

  • Change in renal function

    Baseline to 12 months

  • +1 more secondary outcomes

Study Arms (2)

SGLT2 Inhibitor Group

Patients with chronic heart failure who initiated SGLT2 inhibitor therapy (empagliflozin 10 mg daily or dapagliflozin 10 mg daily) and continued treatment for at least 12 months, in addition to background guideline-directed medical therapy.

Control Group

Patients with chronic heart failure receiving guideline-directed medical therapy without SGLT2 inhibitors, matched for key baseline characteristics.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic heart failure on guideline-directed medical therapy.

You may qualify if:

  • Diagnosis of chronic heart failure
  • Age ≥18 years

You may not qualify if:

  • Incomplete or missing data in electronic medical records
  • Acute cardiac event within 3 months prior to baseline
  • Active malignancy or hematological disease affecting erythropoiesis
  • Use of erythropoiesis-stimulating agents or regular erythrocyte transfusions during the observation period
  • Severe renal insufficiency (eGFR \<15 mL/min/1.73m²)
  • Severe liver insufficiency (AST/ALT \>3× upper limit of normal, bilirubin \>2× upper limit of normal)
  • Known allergy to any SGLT2 inhibitor component
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Heart FailureAnemiaRenal Insufficiency

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

January 1, 2019

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data (IPD) that underline the results reported in future publications (text, tables, figures, and appendices) will be shared upon reasonable request. Shared IPD will include baseline characteristics, outcome measures, and relevant biomarker data, excluding data that could compromise participant privacy or institutional confidentiality.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD will be made available within 6 months after publication of the main results and will remain accessible for at least 5 years thereafter.
Access Criteria
Researches whose proposed use of the data is approved by the principal investigator will be granted access. Proposals should include a concise research plan and statistical analysis outline. Request should be submitted to gregor.poglajen@kclj.si. Approved requesters will sign a data sharing aggrement to ensure data confidentiality and appropriate use.

Locations

SL(1)