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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 : Completed
First Posted : November 15, 2018
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Antoni Bayés Genís, Germans Trias i Pujol Hospital

Tracking Information
First Submitted Date November 12, 2018
First Posted Date November 15, 2018
Last Update Posted Date October 14, 2022
Actual Study Start Date December 21, 2018
Actual Primary Completion Date April 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2018)		 Change in cardiac biomarkers [ Time Frame: 12 months ]
Changes in cardiac biomarkers: NTproBNP, CA125 and ST2
Original Primary Outcome Measures
 (submitted: November 14, 2018)		 Decrease of cardiac biomarkers [ Time Frame: 12 months ]
Changes in cardiac biomarkers: NTproBNP, CA125 and ST2
Change History
Current Secondary Outcome Measures
 (submitted: November 20, 2018)
  • 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.)
  • Improvement of pulmonary congestion [ Time Frame: 12 months ]
    Changes in pulmonary congestion by pulmonary echocardiography
  • Improve in the 6-minute walk [ Time Frame: 12 months ]
    Changes in functional capacity by the 6 minute-walk
Original Secondary Outcome Measures
 (submitted: November 14, 2018)
  • Improvement of quality of life: 5Q questionnaire [ Time Frame: 12 months ]
    Changes in patient's quaility of life by 5Q questionnaire
  • Improvement of pulmonary congestion [ Time Frame: 12 months ]
    Changes in pulmonary congestion by pulmonary echocardiography
  • Improve in the 6-minute walk [ Time Frame: 12 months ]
    Changes in functional capacity by the 6 minute-walk
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure
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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Consecutive patients with type 2 diabetes and heart failure who attend a university hospital heart failure unit.
Condition Heart Failure
Intervention Drug: iSGTL2
Treatment with empaglifozine 10 mg/day (may be also dapaglifozine 10mg/day depending on clinical trial results)
Study Groups/Cohorts Treatment
Patients with diabetes and heart failure that are treated with iSGLT2
Intervention: Drug: iSGTL2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 6, 2021)		 100
Original Estimated Enrollment
 (submitted: November 14, 2018)		 200
Actual Study Completion Date April 4, 2022
Actual Primary Completion Date April 4, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03741972
Other Study ID Numbers ICO-2018-03-PA-Glucosur
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Antoni Bayés Genís, Germans Trias i Pujol Hospital
Original Responsible Party Same as current
Current Study Sponsor Germans Trias i Pujol Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Nuria Alonso Pedrol Germans Trias i Pujol Hospital
PRS Account Germans Trias i Pujol Hospital
Verification Date October 2022