NCT03741972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 21, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

3.3 years

First QC Date

November 12, 2018

Last Update Submit

October 13, 2022

Conditions

Heart Failure

Keywords

Heart failureDiabetesiSGLT2

Outcome Measures

Primary Outcomes (1)

  • Change in cardiac biomarkers

    Changes in cardiac biomarkers: NTproBNP, CA125 and ST2

    12 months

Secondary Outcomes (3)

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

    12 months

  • Improvement of pulmonary congestion

    12 months

  • Improve in the 6-minute walk

    12 months

Study Arms (1)

Treatment

Patients with diabetes and heart failure that are treated with iSGLT2

Drug: iSGTL2

Interventions

iSGTL2DRUG

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

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol University Hospital

Badalona, Spain

Location

MeSH Terms

Conditions

Heart FailureDiabetes Mellitus

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nuria Alonso Pedrol

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Cardiology Unit

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 15, 2018

Study Start

December 21, 2018

Primary Completion

April 4, 2022

Study Completion

April 4, 2022

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations

ES(1)