CompletedNot Applicable

HF Prevalence and Evolution of HF in DM II Patients at High Risk

Greece245 participantsStarted 2020-07-20

Plain-language 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 T2DM patients managed in real-life settings in Greece. A cross-sectional approach will be applied for addressing the primary objective of the study (prevalence of HF) and for determining potential predictors associated with HF stage and the presence of symptomatic HF at enrollment, whereas the prospective cohort phase will capture the 2-year incidence rate of progression to symptomatic HF as well the long-term outcomes of interest. Τhe study will be conducted and reported as per the Good Pharmacoepidemiology Practice and the local rules and regulations. The study will be carried out by approximately 8 cardiology departments that are HF centers of excellence. In addition, aiming at facilitating recruitment, a referral network will be formed comprising endocrinologists, diabetologists, internists and general practitioners treating DM and practicing at the private healthcare sector or at public health facilities. The overall study duration is expected to be 51 months, including an 27-month recruitment period and a 24-month observation period per patient. Εach patient will be followed for up to 24 months, or until death, withdrawal of consent, or physician's decision for patient withdrawal, whichever occurs earlier. Follow-up visit frequency will be determined by the participating Investigators, however study-related data will be collected at enrollment and at 6-, 12-, 18-, and 24-month data collection timepoints post-enrollment. Data collection at enrollment, and at 6 and 24 months post-enrollment will be performed in the context of on-site routine clinical visits at the hospital sites whereas data collection at 12 and 18 months will be performed through telephone contacts.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-melano…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients diagnosed with symptomatic HF

Timeframe: 2 years

Trial details

NCT IDNCT04482283

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-11-21

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