Clinical trial NCT05344963: Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors
Official title: Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sodium-GLucose coTransporter-2 Inhibitors
Heart Failure With Reduced Ejection Fraction
Keywords: Echocardigraphy
Speckle tracking
Strain
SGLT2i
Lead sponsor: Azienda Ospedaliera Universitaria Senese
Sponsor class: OTHER
Collaborators: name: Fondazione Toscana G. Monasterio, Pisa
name: University Of Perugia
name: Section of Cardiology, Department of Medicine, University of Verona, Verona
name: Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome
name: Cardiology and Arrhythmology Clinic, Marche Polytechnic University, 60121 Ancona
name: Cardiology Department, Ospedale Guglielmo da Saliceto - Piacenza
name: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
name: ProMISE, University Hospital Paolo Giaccone, University of Palermo
name: Department of Cardiovascular Disease - AUSL Romagna, Division of Cardiology, Ospedale S. Maria Delle Croci, Viale Randi 5, 48121, Ravenna
name: Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia
name: Department of Biomedical Sciences for Health, University of Milano, Milan
name: Division, of Cardiology, 'A. De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162, Milan
name: Department of Advanced Biomedical Science, Federico II University Hospital, Naples
name: Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara
name: Divisione di Cardiologia, Ospedale S. Maria del Carmine, Rovereto, TN
name: ASST-Rhodense; Ospedale di Circolo di Rho
name: Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno
name: Centro Medico Sant'Agostino, Milano
name: Università Politecnica delle Marche, Ospedali riuniti di Ancona
name: Department of Cardiology, Policlinico Universitario Campus Bio-Medico, Via Álvaro del Portillo, 21, Roma
First posted: 2022-04-25
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Predictors of remodeling and improvement in LV systolic and diastolic function
timeFrame: 18 months
Secondary outcomes:
measure: 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.
timeFrame: 18 months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte
Study officials:
References:
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 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.
citation: 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.