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

NCT04482283 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 245

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • RELATED REGISTRY SEARCH

Sponsors & Collaborators

Principal Investigators

  • IOANNIS PARISSIS · AZ Greece

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2024-11-21
Completion
2024-11-21

Countries

  • Greece

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482283 on ClinicalTrials.gov