Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure

Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure. GLUCOSUR-IC Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03741972

Acronym

GLUCOSUR-IC

Enrollment

100

Registered

2018-11-15

Start date

2018-12-21

Completion date

2022-04-04

Last updated

2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Diabetes, iSGLT2

Brief summary

Inhibitors of the type 2 sodium-glucose co-transporter (iSGLT2) may improve the metabolic and hemodynamic profile in patients with DM2 and heart failure.

Interventions

DRUGiSGTL2

Treatment with empaglifozine 10 mg/day (may be also dapaglifozine 10mg/day depending on clinical trial results)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 Diabetes * HbA1c\> 6.5% * Estimated GF\> 45 ml / min * BMI: ≥25 Kg / m2 * Stable pharmacological treatment of Heart Failure in the last 3 months

Exclusion criteria

* Diabetes type 1 or type LADA (presence of antibodies against GAD and/or IA-2 positive) * DM2 with C-peptide \<1 ng / mL * GEF \<45 ml / min * Recurrent urinary tract infections

Design outcomes

Primary

Measure	Time frame	Description
Change in cardiac biomarkers	12 months	Changes in cardiac biomarkers: NTproBNP, CA125 and ST2

Secondary

Measure	Time frame	Description
Change in quality of life: EuroQol-5D questionnaire (EuroQol five dimension questionnaire)	12 months	Changes in patient's quaility of life by 5Q questionnaire (EuroQol standardised, non-disease-specific instrument for health-related quality of life with 2 parts: first one score from 3-3-3-3 (worst) to 1-1-1-1 (best) and second one which a visual scale scores form 0 (worst)-100 (best). EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208. El EuroQol-5D: una alternativa sencilla para la medición de la calidad de vida relacionada con la salud en atención primaria. Aten Primaria 2001; 28:425-429.)
Improvement of pulmonary congestion	12 months	Changes in pulmonary congestion by pulmonary echocardiography
Improve in the 6-minute walk	12 months	Changes in functional capacity by the 6 minute-walk

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026