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

Germans Trias i Pujol Hospital1 site in 1 country100 target enrollmentDecember 21, 2018

ConditionsHeart Failure

InterventionsiSGTL2

DrugsiSGTL2

Overview

Phase: Not Applicable
Intervention: iSGTL2
Conditions: Heart Failure
Sponsor: Germans Trias i Pujol Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: Change in cardiac biomarkers
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 21, 2018

End Date

April 4, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Germans Trias i Pujol Hospital

Responsible Party

Principal Investigator

Antoni Bayés Genís

Chief of the Cardiology Unit

Germans Trias i Pujol Hospital

Eligibility Criteria

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

Arms & Interventions

Treatment

Patients with diabetes and heart failure that are treated with iSGLT2

Intervention: iSGTL2

Outcomes

Primary Outcomes

Change in cardiac biomarkers

Time Frame: 12 months

Changes in cardiac biomarkers: NTproBNP, CA125 and ST2

Secondary Outcomes

Improvement of pulmonary congestion(12 months)
Improve in the 6-minute walk(12 months)
Change in quality of life: EuroQol-5D questionnaire (EuroQol five dimension questionnaire)(12 months)