New study reveals hidden heart failure risk in diabetes patients
NCT ID NCT04482283
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study followed 245 people with type 2 diabetes and high heart risk for two years to see how many develop heart failure. Researchers collected data from doctor visits and phone calls to track heart health over time. The goal was to better understand who is at risk and how the disease progresses.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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245 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Nov 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
the study encompasses high CV risk T2DM patients undiagnosed with HF at study enrollment who fulfil the study eligibility criteria.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female or male outpatients aged 40 to 80 years (inclusive) at the time of providing informed consent. * T2DM diagnosis within 10 years prior to enrollment. * Patients must have a high or very high cardiovascular risk (as outlined in 2019 ESC Guidelines on diabetes, pre-diabetes and CV diseases). Note: Very high CV risk is defined as having either established CV disease, or other target organ damage (proteinuria, LVH, or retinopathy), or at least three major risk factors. High CV risk is defined as age ≥ 50 years and presence of at least one additional major risk factor. Major risk factors include age ≥ 50 years, hypertension, dyslipidemia, smoking, and obesity. * Patients must have available medical records for data abstraction to meet the objectives of the study. * Written signed and dated informed consent. Exclusion Criteria: * Diagnosis of type 1 DM. * Treatment with SGLT2 inhibitor at the time of providing informed consent. * History of HF (defined as current or previous receipt of treatment prescribed for the management of HF, and/or hospitalization for HF at any time in the past). * Patients with limitations in their functional capacity that, as per the physician's judgment, are attributed to non-cardiac medical reason or condition (such as lung disease, musculoskeletal disorders, infection, endocrine disorders etc.). * History of any malignancy within the 5-year period prior to enrollment (with the exception of successfully treated non-melanoma skin cancers). * Chronic cystitis and/or recurrent genital or urinary tract infections (3 or more in the last year). * Acute kidney injury or rapidly progressing renal disease. * Severe renal impairment (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73m2 using the CKD-EPI equation). * Hematuria (confirmed by microscopic evaluation) with no explanation as judged by the study physician. * HbA1c level ≥12%. * Aspartate or alanine aminotransferase \>3 x upper limit of normal (ULN) or total bilirubin \>2.5xULN. * Pregnant or breastfeeding patient. * Patients with lifetime expectancy less than 2 years due to any non-cardiovascular cause or with any non-cardiac condition which, in the judgment of the Investigator, may render the patient unable to complete the study. * Patients who are currently receiving treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment. * Patients who have already been enrolled in this study or in a study of the same design which the physician has good reasons to believe that it is this study (to exclude enrollment of the same patient by two different sites).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Alexandroupoli, 68100, Greece
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Research Site
Athens, 10676, Greece
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Research Site
Athens, 11526, Greece
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Research Site
Athens, 11527, Greece
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Research Site
Athens, 12462, Greece
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Research Site
Heraklion, 71500, Greece
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Research Site
Larissa, 41110, Greece
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Research Site
Pátrai, 26504, Greece
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Research Site
Thessaloniki, 54636, Greece
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Research Site
Thessaloniki, 54642, Greece
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