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Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study)
(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 D...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573953/ https://www.ncbi.nlm.nih.gov/pubmed/37834963 http://dx.doi.org/10.3390/jcm12196319 |
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author | Parissis, John Georgiou, Christos Bistola, Vasiliki Karavidas, Apostolos Vassilikos, Vassilios P. Kanakakis, John Davlouros, Periklis Tziakas, Dimitrios N. Alexanian, Ioannis P. Kochiadakis, George Triposkiadis, Filippos Karvounis, Haralambos Gourlis, Dimitrios Papoutsidakis, Nikolaos Polyzogopoulou, Effie Vlachopoulos, Charalambos |
author_facet | Parissis, John Georgiou, Christos Bistola, Vasiliki Karavidas, Apostolos Vassilikos, Vassilios P. Kanakakis, John Davlouros, Periklis Tziakas, Dimitrios N. Alexanian, Ioannis P. Kochiadakis, George Triposkiadis, Filippos Karvounis, Haralambos Gourlis, Dimitrios Papoutsidakis, Nikolaos Polyzogopoulou, Effie Vlachopoulos, Charalambos |
author_sort | Parissis, John |
collection | PubMed |
description | (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). |
format | Online Article Text |
id | pubmed-10573953 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-105739532023-10-14 Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study) Parissis, John Georgiou, Christos Bistola, Vasiliki Karavidas, Apostolos Vassilikos, Vassilios P. Kanakakis, John Davlouros, Periklis Tziakas, Dimitrios N. Alexanian, Ioannis P. Kochiadakis, George Triposkiadis, Filippos Karvounis, Haralambos Gourlis, Dimitrios Papoutsidakis, Nikolaos Polyzogopoulou, Effie Vlachopoulos, Charalambos J Clin Med Study Protocol (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). MDPI 2023-09-30 /pmc/articles/PMC10573953/ /pubmed/37834963 http://dx.doi.org/10.3390/jcm12196319 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Study Protocol Parissis, John Georgiou, Christos Bistola, Vasiliki Karavidas, Apostolos Vassilikos, Vassilios P. Kanakakis, John Davlouros, Periklis Tziakas, Dimitrios N. Alexanian, Ioannis P. Kochiadakis, George Triposkiadis, Filippos Karvounis, Haralambos Gourlis, Dimitrios Papoutsidakis, Nikolaos Polyzogopoulou, Effie Vlachopoulos, Charalambos Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study) |
title | Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study) |
title_full | Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study) |
title_fullStr | Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study) |
title_full_unstemmed | Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study) |
title_short | Rationale and Design of Heart Failure Prevalence and Evolution of Heart Failure in Diabetes Mellitus Type II Patients at High Risk (HF-LanDMark Study) |
title_sort | rationale and design of heart failure prevalence and evolution of heart failure in diabetes mellitus type ii patients at high risk (hf-landmark study) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573953/ https://www.ncbi.nlm.nih.gov/pubmed/37834963 http://dx.doi.org/10.3390/jcm12196319 |
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