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| Name | Class |
|---|---|
| Fondazione Toscana G. Monasterio, Pisa | UNKNOWN |
| University Of Perugia | OTHER |
| Section of Cardiology, Department of Medicine, University of Verona, Verona | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium-GLucose coTransporter-2 inhibitors | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte | Siena | 53100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30415602 | Result | 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. | |
| 31535829 |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| OTHER |
| Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona | UNKNOWN |
| Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza | UNKNOWN |
| Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | OTHER |
| ProMISE, University Hospital Paolo Giaccone, University of Palermo | UNKNOWN |
| Department of Cardiovascular Disease - AUSL Romagna, Division of Cardiology, Ospedale S. Maria Delle Croci, Viale Randi 5, 48121, Ravenna | UNKNOWN |
| Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia | UNKNOWN |
| Department of Biomedical Sciences for Health, University of Milano, Milan | UNKNOWN |
| Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan | UNKNOWN |
| Department of Advanced Biomedical Science, Federico II University Hospital, Naples | UNKNOWN |
| Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara | UNKNOWN |
| Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN | UNKNOWN |
| ASST-Rhodense; Ospedale di Circolo di Rho | UNKNOWN |
| Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno | UNKNOWN |
| Centro Medico Sant'Agostino, Milano | UNKNOWN |
| Università Politecnica delle Marche, Ospedali riuniti di Ancona | UNKNOWN |
| Department of Cardiology, Policlinico Universitario Campus Bio-Medico, Via Álvaro del Portillo, 21, Roma | UNKNOWN |
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| 18 months |
| Result |
| McMurray 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. |
| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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