Status:
COMPLETED
HF Prevalence and Evolution of HF in DM II Patients at High Risk
Lead Sponsor:
AstraZeneca
Conditions:
RELATED REGISTRY SEARCH
Eligibility:
All Genders
40-80 years
Brief Summary
This is an epidemiological, single-country, multicenter, 2-year prospective cohort study based on both primary and secondary data collection, which will include a representative sample of 300 eligible...
Detailed Description
Background/Rationale: Heart failure (HF) is a major contributor to cardiovascular morbidity and mortality, and one of the most common urgent cardiovascular (CV) presentations in patients with diabete...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 21 2024
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT04482283
Start Date
July 20 2020
End Date
November 21 2024
Last Update
November 24 2025
Active Locations (10)
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1
Research Site
Alexandroupoli, Greece, 68100
2
Research Site
Athens, Greece, 10676
3
Research Site
Athens, Greece, 11526
4
Research Site
Athens, Greece, 11527