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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— DISCOVERSGLT2i  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05344963
• Other study ID #: DISCOVER SGLT2i
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: April 2024

Study information

• Verified date: May 2022
• Source: Azienda Ospedaliera Universitaria Senese
• Contact: Matteo Cameli, Prof
• Phone: +39 0577/585377
• Email: matteo.cameli[@]unisi.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Providing informed consent prior to any specific study procedure

2. Female or male outpatient patients > 18 years

3. Have heart failure and left ventricular ejection fraction <= 40%, according to the ESC definition

4. 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

Exclusion Criteria:

1. Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)

2. Age <18 years

3. For women only - ongoing pregnancy (confirmed with positive pregnancy test)

4. For women only - breastfeeding

5. Poor quality of echocardiographic images which compromises a correct speckle tracking analysis

6. Failure to sign informed consent.

7. Previous treatment with SGLT2i.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Drug:
• Sodium-GLucose coTransporter-2 inhibitors
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

Locations

Country	Name	City	State
Italy	UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte	Siena

Sponsors (21)

Lead Sponsor

Collaborator

Matteo Cameli

ASST-Rhodense; Ospedale di Circolo di Rho, Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno, Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona, Cardiology and Cardiovascular Pathophysiology - Heart Failure Unit; "Santa Maria della Misericordia" Hospital, University of Perugia, Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza, Centro Medico Sant'Agostino, Milano, Department of Advanced Biomedical Science, Federico II University Hospital, Naples, Department of Biomedical Sciences for Health, University of Milano, Milan, Department of Cardiology, Policlinico Universitario Campus Bio-Medico, Via Álvaro del Portillo, 21, Roma, Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, 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 Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara, Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan, Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN, Fondazione Toscana G. Monasterio, Pisa, ProMISE, University Hospital Paolo Giaccone, University of Palermo, Section of Cardiology, Department of Medicine, University of Verona, Verona, Università Politecnica delle Marche, Ospedali riuniti di Ancona, University Cardiology Unit, Cardiothoracic Department, Polyclinic University Hospital, Bari

Country where clinical trial is conducted

Italy, 

References & Publications (2)

McMurray JJV, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlávek J, Böhm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukát A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman C — View Citation

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 In — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	18 months