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Completed

NCT Number: NCT03741972

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Germans Trias i Pujol University Hospital

Badalona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iSGTL2

Drug

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

Primary outcomes

  1. Change in cardiac biomarkers

    Time frame: 12 months

    Changes in cardiac biomarkers: NTproBNP, CA125 and ST2

Secondary outcomes

  1. Change in quality of life: EuroQol-5D questionnaire (EuroQol five dimension questionnaire)

    Time frame: 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.)

  2. Improvement of pulmonary congestion

    Time frame: 12 months

    Changes in pulmonary congestion by pulmonary echocardiography

  3. Improve in the 6-minute walk

    Time frame: 12 months

    Changes in functional capacity by the 6 minute-walk

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study 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

Acronym: GLUCOSUR-IC

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2018
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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