Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors

NCT05344963 | Completed

• 1 other identifier: DISCOVER SGLT2i
• Study Type: observational
• Target: 503
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sodium-GLucose coTransporter-2 Inhibitors; Heart Failure With Reduced Ejection Fraction

Keywords

Echocardigraphy; Speckle tracking; Strain; SGLT2i

Outcome Measures

Primary Outcomes (1)

• 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

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.

  18 months

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matteo Cameli: lead
• Fondazione Toscana G. Monasterio, Pisa: collaborator
• University Of Perugia: collaborator
• Section of Cardiology, Department of Medicine, University of Verona, Verona: collaborator
• Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome: collaborator
• Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona: collaborator
• Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza: collaborator
• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: collaborator
• ProMISE, University Hospital Paolo Giaccone, University of Palermo: collaborator
• Department of Cardiovascular Disease - AUSL Romagna, Division of Cardiology, Ospedale S. Maria Delle Croci, Viale Randi 5, 48121, Ravenna: collaborator
• Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia: collaborator
• Department of Biomedical Sciences for Health, University of Milano, Milan: collaborator
• Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan: collaborator
• Department of Advanced Biomedical Science, Federico II University Hospital, Naples: collaborator
• Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara: collaborator
• Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN: collaborator
• ASST-Rhodense; Ospedale di Circolo di Rho: collaborator
• Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno: collaborator
• Centro Medico Sant'Agostino, Milano: collaborator
• Università Politecnica delle Marche, Ospedali riuniti di Ancona: collaborator
• Department of Cardiology, Policlinico Universitario Campus Bio-Medico, Via Álvaro del Portillo, 21, Roma: collaborator

Study Sites (1)

UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte

Siena, 53100, Italy

Location

Related Publications (2)

• 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.

  PMID: 30415602 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.

  PMID: 31535829 RESULT

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: April 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

IT (1)