Sodium-GLucose coTransporter-2 InhibitorsDISCOVERSGLT2iNCT05344963
Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors
An observational study of Sodium-GLucose coTransporter-2 Inhibitors and Heart Failure With Reduced Ejection Fraction, run by Matteo Cameli at 1 site in Italy.
Trial summary
It is an observational, cohort, prospective, multicentre, Italian, non-profit study, with the aim of evaluating the modification of conventional and advanced echocardiographic parameters, focusing on speckle tracking and three-dimensional echocardiography (optional), in patients with HFrEF after treatment with SGLT2i… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sodium-GLucose coTransporter-2 Inhibitors, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Sodium-GLucose coTransporter-2 inhibitors
- How many people
- 503 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 1 Jun 2024
- 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: Outpatients with heart failure and EF <= 40% and already on an ACE inhibitor / angiotensin-neprilysin receptor (ARNI) inhibitor, a beta blocker and an aldosterone receptor inhibitor, where treatment will be initiated with SGLT2i for optimization of therapy for heart failure, according to the latest ESC guidelines.
Who may be able to join
- Providing informed consent prior to any specific study procedure
- Female or male outpatient patients > 18 years
- Have heart failure and left ventricular ejection fraction <= 40%, according to the ESC definition
- Already on therapy with an angiotensin converting enzyme (ACE) inhibitor or sacubitril / valsartan, a beta-blocker and mineralocorticoid receptor antagonist (MRA) and be initiated for treatment with SGLT2i for therapy optimization
Who cannot join
- Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)
- Age <18 years
- For women only - ongoing pregnancy (confirmed with positive pregnancy test)
- For women only - breastfeeding
- Poor quality of echocardiographic images which compromises a correct speckle tracking analysis
- Failure to sign informed consent.
- Previous treatment with SGLT2i.
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte
Siena, 53100
About this study
It is an observational, cohort, prospective, multicentre, Italian, non-profit study, with the aim of evaluating the modification of conventional and advanced echocardiographic parameters, focusing on speckle tracking and three-dimensional echocardiography (optional), in patients with HFrEF after treatment with SGLT2i Dapagliflozin and Empagliflozin.
Participation in the study will last for approximately 18 months, and a total of 300 patients will be enrolled at the various Research Centers.
Read more
The enrolled patients will undergo a first evaluation in which the anamnestic, clinical and conventional and advanced echocardiographic data will be recorded. At this point, the patient will start SGLT2i.
After starting SGLT2i, a second evaluation will be carried out with a cardiological visit at 6 months, in which the same data listed above will then be recorded.
At the end of the evaluation, the clinical follow-up will be continued for the duration of 1 year, in number and frequency according to clinical indication.
- Being tested
- Sodium-GLucose coTransporter-2 inhibitors
- Keywords
- Echocardigraphy, Speckle tracking, Strain, SGLT2i
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium-GLucose coTransporter-2 inhibitorsDrug
Evaluation of the modification of conventional and advanced echocardiographic parameters, focusing on speckle tracking and three-dimensional echocardiography (optional), in patients with HFrEF after treatment with the SGLT2i drugs Dapagliflozin and Empagliflozin
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of remodeling and improvement in LV systolic and diastolic function
A univariate and multivariate logistic regression analysis will be performed to search for predictors of remodeling and improvement in LV systolic and diastolic function at 6 months, with particular attention to advanced echocardiography parameters.
Measured: 18 months
Secondary outcomes (1)
Combined outcome 12 months from the third evaluation (18 months from the start of therapy) including death from cardiovascular causes, appropriate defibrillator discharge, hospitalizations or episodes of atrial fibrillation.
Uni and multivariate Cox analyzes will be performed for predictors of cardiovascular events and the quality of the model will then be estimated by time-dependent ROC analysis.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Apr 2022
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sodium-GLucose coTransporter-2 InhibitorsStudies 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
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matteo Cameli
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Toscana G. Monasterio, Pisa, University Of Perugia, Section of Cardiology, Department of Medicine, University of Verona, Verona, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona, Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, ProMISE, University Hospital Paolo Giaccone, University of Palermo, Department of Cardiovascular Disease - AUSL Romagna, Division of Cardiology, Ospedale S. Maria Delle Croci, Viale Randi 5, 48121, Ravenna, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Department of Biomedical Sciences for Health, University of Milano, Milan, Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan, Department of Advanced Biomedical Science, Federico II University Hospital, Naples, Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara, Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN, ASST-Rhodense; Ospedale di Circolo di Rho, Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno, Centro Medico Sant'Agostino, Milano, Università Politecnica delle Marche, Ospedali riuniti di Ancona, Campus Bio-Medico University
- Responsible party
- Sponsor-investigator, Matteo Cameli, Azienda Ospedaliera Universitaria Senese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344963
- Sponsor's protocol ID
- DISCOVER SGLT2i
- Acronym
- DISCOVERSGLT2i
- Status last verified
- Feb 2025
- First submitted
- 19 Apr 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.
PubMed 30415602McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
PubMed 31535829
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors
- ClinicalTrials.gov ID
- NCT05344963
- Acronym / sponsor ID
- DISCOVERSGLT2i / DISCOVER SGLT2i
- Keywords
- Echocardigraphy, Speckle tracking, Strain, SGLT2i
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Matteo CameliUniversity, hospital or other
- Collaborators
- Fondazione Toscana G. Monasterio, Pisa, University Of Perugia, Section of Cardiology, Department of Medicine, University of Verona, Verona, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona, Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, ProMISE, University Hospital Paolo Giaccone, University of Palermo, Department of Cardiovascular Disease - AUSL Romagna, Division of Cardiology, Ospedale S. Maria Delle Croci, Viale Randi 5, 48121, Ravenna, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Department of Biomedical Sciences for Health, University of Milano, Milan, Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan, Department of Advanced Biomedical Science, Federico II University Hospital, Naples, Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara, Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN, ASST-Rhodense; Ospedale di Circolo di Rho, Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno, Centro Medico Sant'Agostino, Milano, Università Politecnica delle Marche, Ospedali riuniti di Ancona, Campus Bio-Medico University
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 25 Apr 2022 (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.
It is an observational, cohort, prospective, multicentre, Italian, non-profit study, with the aim of evaluating the modification of conventional and advanced echocardiographic parameters, focusing on speckle tracking and three-dimensional echocardiography (optional), in patients with HFrEF after treatment with SGLT2i Dapagliflozin and Empagliflozin.
Participation in the study will last for approximately 18 months, and a total of 300 patients will be enrolled at the various Research Centers.
The enrolled patients will undergo a first evaluation in which the anamnestic, clinical and conventional and advanced echocardiographic data will be recorded. At this point, the patient will start SGLT2i.
After starting SGLT2i, a second evaluation will be carried out with a cardiological visit at 6 months, in which the same data listed above will then be recorded.
At the end of the evaluation, the clinical follow-up will be continued for the duration of 1 year, in number and frequency according to clinical indication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with heart failure and EF <= 40% and already on an ACE inhibitor / angiotensin-neprilysin receptor (ARNI) inhibitor, a beta blocker and an aldosterone receptor inhibitor, where treatment will be initiated with SGLT2i for optimization of therapy for heart failure, according to the latest ESC guidelines.
Key inclusion criteria (4 listed)
- Providing informed consent prior to any specific study procedure
- Female or male outpatient patients > 18 years
- Have heart failure and left ventricular ejection fraction <= 40%, according to the ESC definition
- Already on therapy with an angiotensin converting enzyme (ACE) inhibitor or sacubitril / valsartan, a beta-blocker and mineralocorticoid receptor antagonist (MRA) and be initiated for treatment with SGLT2i for therapy optimization
Key exclusion criteria (7 listed)
- Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)
- Age <18 years
- For women only - ongoing pregnancy (confirmed with positive pregnancy test)
- For women only - breastfeeding
- Poor quality of echocardiographic images which compromises a correct speckle tracking analysis
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 |
|---|---|---|
| Sodium-GLucose coTransporter-2 inhibitorsEvaluation of the modification of conventional and advanced echocardiographic parameters, focusing on speckle tracking and three-dimensional echocardiography (optional), in patients with HFrEF after treatment with the SGLT2i drugs Dapagliflozin and Empagliflozin | Drug | – |
Primary outcome
Predictors of remodeling and improvement in LV systolic and diastolic function
Time frame: 18 months
A univariate and multivariate logistic regression analysis will be performed to search for predictors of remodeling and improvement in LV systolic and diastolic function at 6 months, with particular attention to advanced echocardiography parameters.
1 secondary outcome
Combined outcome 12 months from the third evaluation (18 months from the start of therapy) including death from cardiovascular causes, appropriate defibrillator discharge, hospitalizations or episodes of atrial fibrillation.
Time frame: 18 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 7 Feb 2025.
- Results publication: PubMed 30415602Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.
- Results publication: PubMed 31535829McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sodium-GLucose coTransporter-2 Inhibitors and Heart Failure With Reduced Ejection Fraction, run by Matteo Cameli at 1 site in Italy.
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 4 inclusion and 7 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 7 Feb 2025. 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 Italy. 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?
Predictors of remodeling and improvement in LV systolic and diastolic function (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05344963, which also lists 2 linked publications.
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 7 Feb 2025.