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. 2023 Sep 30;12(19):6319.
doi: 10.3390/jcm12196319.

Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study)

John Parissis  1 , Christos Georgiou  1 , Vasiliki Bistola  2 , Apostolos Karavidas  3 , Vassilios P Vassilikos  4 , John Kanakakis  5 , Periklis Davlouros  6 , Dimitrios N Tziakas  7 , Ioannis P Alexanian  8 , George Kochiadakis  9 , Filippos Triposkiadis  10 , Haralambos Karvounis  11 , Dimitrios Gourlis  12 , Nikolaos Papoutsidakis  12 , Effie Polyzogopoulou  1 , Charalambos Vlachopoulos  13
Affiliations

Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study)

John Parissis et al. J Clin Med. .

Abstract

(1) Background: Patients with diabetes mellitus (DM) are at increased risk for heart failure (HF). Accurate data regarding the prevalence of HF stages among diabetics in Greece are scarce. (2) Aim: The present study will examine the prevalence and evolution of HF stages among patients with type II DM (T2DM) diagnosed in the past 10 years, with no previous history of HF and at high CV risk, in Greece, as well as will explore the potential determinants of the development of symptomatic HF in these patients. (3) Methods: Through a non-interventional, epidemiological, single-country, multi-center, prospective cohort study design, a sample of 300 consecutive patients will be enrolled in 11 cardiology departments that are HF centers of excellence. Patients will be either self-referred or referred by primary or secondary care physicians and will be followed for up to 24 months. Demographic, clinical, echocardiography, electrocardiography, cardiac biomarkers (troponin, NT-proBNP) and health-related quality of life questionnaire data will be recorded as well as clinical events, including mortality, HF hospitalizations and HF-related healthcare resource utilization. The primary outcomes are the proportion of patients diagnosed with symptomatic HF (ACC/AHA Stage C) at enrolment in the overall study population and the proportions of patients with HF stages A, B and C, as well as by NYHA functional classification in the overall study population. (4) Conclusions: The HF-LanDMark study is the first epidemiological study that will assess the prevalence of HF among T2DM patients in Greece that could potentially enhance prompt therapeutic interventions shown to delay the development of HF in the T2DM patient population (HF-LanDMark, Clinical Trials.gov number, NCT04482283).

Keywords: heart failure incidence; heart failure prevalence; quality of life; sodium–glucose cotransporter-2 inhibitors; type 2 diabetes mellitus.

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Conflict of interest statement

J.P. has received honoraria for lectures or advisory boards from Astra Zeneca, Bayer, Boehringer Ingelheim, Orion Pharma, Pfizer, Servier, AOP Orphan, and Roche Diagnostics. VB has received honoraria for lectures or advisory boards from Astra Zeneca, Bayer, Boehringer Ingelheim, Novartis and Pfizer. AK has received honoraria for lectures from Astra Zeneca. VPV has received honoraria and departmental funding from Astra-Zeneca. IA has received honoraria for lectures, advisory boards or clinical trial participation from Novartis, Boehringer Ingelheim and Astra Zeneca. C.G., J.K., P.D., D.T., G.K., F.T., H.K. and C.V. report no conflicts of interest relevant to this publication. N.P. and D.G. are employees of Astra Zeneca Greece.

Figures

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Figure 1
Study design and flow chart.
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