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

Last updated: February 5, 2025
Sponsor: Matteo Cameli
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

Sodium-GLucose coTransporter-2 inhibitors

Clinical Study ID

NCT05344963
DISCOVER SGLT2i
  • Ages > 18
  • All Genders

Study 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

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 theESC definition

  4. Already on therapy with an angiotensin converting enzyme (ACE) inhibitor orsacubitril / valsartan, a beta-blocker and mineralocorticoid receptor antagonist (MRA) and be initiated for treatment with SGLT2i for therapy optimization

Exclusion

Exclusion Criteria:

  1. Involvement in study planning and / or conducting (applies to both investigatorstaff 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 speckletracking analysis

  6. Failure to sign informed consent.

  7. Previous treatment with SGLT2i.

Study Design

Total Participants: 503
Treatment Group(s): 1
Primary Treatment: Sodium-GLucose coTransporter-2 inhibitors
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
June 01, 2024

Connect with a study center

  • UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte

    Siena, 53100
    Italy

    Site Not Available

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