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

Completed

• Conditions: Heart Failure
• Interventions: Drug: iSGTL2

• Registration Number: NCT03741972
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Study Start: 2018-12-21
• Primary Completion: 2022-04-04
• Study Completion: 2022-04-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	iSGTL2	Patients with diabetes and heart failure that are treated with iSGLT2

Primary Outcome Measures

Name	Time	Method
Change in cardiac biomarkers	12 months	Changes in cardiac biomarkers: NTproBNP, CA125 and ST2

Secondary Outcome Measures

Name	Time	Method
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
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.)

Trial Locations

Locations (1)

Germans Trias i Pujol University Hospital; 🇪🇸 Badalona, Spain