NCT05344963Completed
Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors
Source: ClinicalTrials.gov · Last updated 7 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 503 (actual)
- First submitted
- 19 Apr 2022
- Start date
- 1 Apr 2022
- Primary completion date
- 1 May 2024
- Lead sponsor
- Matteo Cameli
- Diseases
- Heart failure
- NCT number
- NCT05344963
What you commit to
- Study type: Observational
- Participants enrolled: 503
- From 1 Apr 2022 to the primary completion date, 1 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with SGLT2i.
Other illness
- Failure to sign informed consent.
Age
- Age \<18 years
Other
- Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.