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

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ClinicalTrials.gov Identifier: NCT03741972
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Antoni Bayés Genís, 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.

Condition or disease Intervention/treatment
Heart Failure Drug: iSGTL2

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Treatment
Patients with diabetes and heart failure that are treated with iSGLT2
Drug: iSGTL2
Treatment with empaglifozine 10 mg/day (may be also dapaglifozine 10mg/day depending on clinical trial results)




Primary Outcome Measures :
  1. Change in cardiac biomarkers [ Time Frame: 12 months ]
    Changes in cardiac biomarkers: NTproBNP, CA125 and ST2


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with type 2 diabetes and heart failure who attend a university hospital heart failure unit.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741972


Contacts
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Contact: Mar Domingo 0034934978772 madote@gmail.com

Locations
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Spain
Germans Trias i Pujol University Hospital Recruiting
Badalona, Spain
Contact: Antoni Bayés Genís         
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
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Principal Investigator: Nuria Alonso Pedrol Germans Trias i Pujol Hospital

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Responsible Party: Antoni Bayés Genís, Chief of the Cardiology Unit, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT03741972     History of Changes
Other Study ID Numbers: ICO-2018-03-PA-Glucosur
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Antoni Bayés Genís, Germans Trias i Pujol Hospital:
Heart failure
Diabetes
iSGLT2
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases