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

October 13, 2022 updated by: Antoni Bayés Genís, Germans Trias i Pujol Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain
        • Germans Trias i Pujol University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with type 2 diabetes and heart failure who attend a university hospital heart failure unit.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiac biomarkers
Time Frame: 12 months
Changes in cardiac biomarkers: NTproBNP, CA125 and ST2
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
12 months
Improvement of pulmonary congestion
Time Frame: 12 months
Changes in pulmonary congestion by pulmonary echocardiography
12 months
Improve in the 6-minute walk
Time Frame: 12 months
Changes in functional capacity by the 6 minute-walk
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Investigators

  • Principal Investigator: Nuria Alonso Pedrol, Germans Trias I Pujol Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2018

Primary Completion (ACTUAL)

April 4, 2022

Study Completion (ACTUAL)

April 4, 2022

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (ACTUAL)

November 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2018-03-PA-Glucosur

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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