Heart FailureGLUCOSUR-ICNCT03741972
Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure
An observational study of Heart Failure, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- iSGTL2
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2018to 4 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with type 2 diabetes and heart failure who attend a university hospital heart failure unit.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Inhibitors of the type 2 sodium-glucose co-transporter (iSGLT2) may improve the metabolic and hemodynamic profile in patients with DM2 and heart failure.
- Conditions
- Heart Failure
- Being tested
- iSGTL2
- Keywords
- Heart failure, Diabetes, iSGLT2
- Medical subject headings
- Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSGTL2Drug
Treatment with empaglifozine 10 mg/day (may be also dapaglifozine 10mg/day depending on clinical trial results)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients with diabetes and heart failure that are treated with iSGLT2 Receives: Drug: iSGTL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac biomarkers
Changes in cardiac biomarkers: NTproBNP, CA125 and ST2
Measured: 12 months
Secondary outcomes (3)
Change in quality of life: EuroQol-5D questionnaire (EuroQol five dimension questionnaire)
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.)
Measured: 12 months
Improvement of pulmonary congestion
Changes in pulmonary congestion by pulmonary echocardiography
Measured: 12 months
Improve in the 6-minute walk
Changes in functional capacity by the 6 minute-walk
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start21 Dec 2018
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoni Bayés Genís, Germans Trias i Pujol Hospital
- Investigators
- Nuria Alonso Pedrol, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741972
- Sponsor's protocol ID
- ICO-2018-03-PA-Glucosur
- Acronym
- GLUCOSUR-IC
- Status last verified
- Oct 2022
- First submitted
- 12 Nov 2018
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03741972
- Acronym / sponsor ID
- GLUCOSUR-IC / ICO-2018-03-PA-Glucosur
- Conditions
- Heart Failure
- Keywords
- Heart failure, Diabetes, iSGLT2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: iSGTL2Patients with diabetes and heart failure that are treated with iSGLT2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with type 2 diabetes and heart failure who attend a university hospital heart failure unit.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iSGTL2Treatment with empaglifozine 10 mg/day (may be also dapaglifozine 10mg/day depending on clinical trial results) | Drug | Treatment |
Primary outcome
Change in cardiac biomarkers
Time frame: 12 months
Changes in cardiac biomarkers: NTproBNP, CA125 and ST2
3 secondary outcomes
Change in quality of life: EuroQol-5D questionnaire (EuroQol five dimension questionnaire)
Time frame: 12 months
Improvement of pulmonary congestion
Time frame: 12 months
Improve in the 6-minute walk
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuria Alonso Pedrol principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac biomarkers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.