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

Heart Failure Clinical Trial

— GLUCOSUR-IC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741972
• Other study ID #: ICO-2018-03-PA-Glucosur
• Status: Completed
• Start date: December 21, 2018
• Est. completion date: April 4, 2022

Study information

• Verified date: October 2022
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• iSGTL2
Treatment with empaglifozine 10 mg/day (may be also dapaglifozine 10mg/day depending on clinical trial results)

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol University Hospital	Badalona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiac biomarkers	Changes in cardiac biomarkers: NTproBNP, CA125 and ST2	12 months
Secondary	Change in quality of life: EuroQol-5D questionnaire (EuroQol five dimension questionnaire)	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.)	12 months
Secondary	Improvement of pulmonary congestion	Changes in pulmonary congestion by pulmonary echocardiography	12 months
Secondary	Improve in the 6-minute walk	Changes in functional capacity by the 6 minute-walk	12 months