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

NCT ID: NCT03741972

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-21

Study Completion Date

2022-04-04

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

Patients with diabetes and heart failure that are treated with iSGLT2

iSGTL2

Intervention Type DRUG

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

Interventions

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iSGTL2

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Germans Trias i Pujol Hospital

OTHER

Sponsor Role lead

Responsible Party

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Antoni Bayés Genís

Chief of the Cardiology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuria Alonso Pedrol

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Locations

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Germans Trias i Pujol University Hospital

Badalona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ICO-2018-03-PA-Glucosur

Identifier Type: -

Identifier Source: org_study_id

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