- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05344963
Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors (DISCOVERSGLT2i)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Matteo Cameli, Prof
- Phone Number: +39 0577/585377
- Email: matteo.cameli@unisi.it
Study Locations
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-
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Siena, Italy, 53100
- Recruiting
- UOC Diagnostica Cardiovascolare, AOU Senese Policlinico Le Scotte
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Contact:
- Matteo Cameli, Prof
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictors of remodeling and improvement in LV systolic and diastolic function
Time Frame: 18 months
|
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.
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 18 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DISCOVER SGLT2i
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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