scholarly journals Disease overarching mechanisms that explain and predict outcome of patients with high cardiovascular risk: rationale and design of the Berlin Long-term Observation of Vascular Events (BeLOVE) study

2019 ◽  
Author(s):  
Bob Siegerink ◽  
Joachim Weber ◽  
Michael Ahmadi ◽  
Kai-Uwe Eckardt ◽  
Frank Edelmann ◽  
...  

AbstractBackgroundCardiovascular disease (CVD) is the leading cause of premature death worldwide. Effective and individualized treatment requires exact knowledge about both risk factors and risk estimation. Most evidence for risk prediction currently comes from population-based studies on first incident cardiovascular events. In contrast, little is known about the relevance of risk factors for the outcome of patients with established CVD or those who are at high risk of CVD, including patients with type 2 diabetes. In addition, most studies focus on individual diseases, whereas less is known about disease overarching risk factors and cross-over risk.AimThe aim of BeLOVE is to improve short- and long-term prediction and mechanistic understanding of cardiovascular disease progression and outcomes in very high-risk patients, both in the acute as well as in the chronic phase, in order to provide the basis for improved, individualized management.Study designBeLOVE is an observational prospective cohort study of patients of both sexes aged >18 in selected Berlin hospitals, who have a high risk of future cardiovascular events, including patients with a history of acute coronary syndrome (ACS), acute stroke (AS), acute heart failure (AHF), acute kidney injury (AKI) or type 2 diabetes with manifest target-organ damage. BeLOVE includes 2 subcohorts: The acute subcohort includes 6500 patients with ACS, AS, AHF, or AKI within 2-8 days after their qualifying event, who undergo a structured interview about medical history as well as blood sample collection. The chronic subcohort includes 6000 patients with ACS, AS, AHF, or AKI 90 days after event, and patients with type 2 diabetes (T2DM) and target-organ damage. These patients undergo a 6-8 hour deep phenotyping program, including detailed clinical phenotyping from a cardiological, neurological and metabolic perspective, questionnaires including patient-reported outcome measures (PROMs)as well as magnetic resonance imaging. Several biological samples are collected (i.e. blood, urine, saliva, stool) with blood samples collected in a fasting state, as well as after a metabolic challenge (either nutritional or cardiopulmonary exercise stress test). Ascertainment of major adverse cardiovascular events (MACE) will be performed in all patients using a combination of active and passive follow-up procedures, such as on-site visits (if applicable), telephone interviews, review of medical charts, and links to local health authorities. Additional phenotyping visits are planned at 2, 5 and 10 years after inclusion into the chronic subcohort.Future perspectiveBeLOVE provides a unique opportunity to study both the short- and long-term disease course of patients at high cardiovascular risk through innovative and extensive deep phenotyping. Moreover, the unique study design provides opportunities for acute and post-acute inclusion and allows us to derive two non-nested yet overlapping sub-cohorts, tailored for upcoming research questions. Thereby, we aim to study disease-overarching research questions, to understand crossover risk, and to find similarities and differences between clinical phenotypes of patients at high cardiovascular risk.

2019 ◽  
Author(s):  
Bob Siegerink ◽  
Joachim Weber ◽  
Michael Ahmadi ◽  
Kai-Uwe Eckardt ◽  
Frank Edelmann ◽  
...  

Background: Cardiovascular disease (CVD) is the leading cause of premature death worldwide. Effective and individualized treatment requires exact knowledge about both risk factors and risk estimation. Most evidence for risk prediction currently comes from population-based studies on first incident cardiovascular events. In contrast, little is known about the relevance of risk factors for the outcome of patients with established CVD or those who are at high risk of CVD, including patients with type 2 diabetes. In addition, most studies focus on individual diseases, whereas less is known about disease overarching risk factors and cross-over risk. Aim: The aim of BeLOVE is to improve short- and long-term prediction and mechanistic understanding of cardiovascular disease progression and outcomes in very high-risk patients, both in the acute as well as in the chronic phase, in order to provide the basis for improved, individualized management. Study design: BeLOVE is an observational prospective cohort study of patients of both sexes aged >18 in selected Berlin hospitals, who have a high risk of future cardiovascular events, including patients with a history of acute coronary syndrome (ACS), acute stroke (AS), acute heart failure (AHF), acute kidney injury (AKI) or type 2 diabetes with manifest target-organ damage. BeLOVE includes 2 subcohorts: The acute subcohort includes 6500 patients with ACS, AS, AHF, or AKI within 2-8 days after their qualifying event, who undergo a structured interview about medical history as well as blood sample collection. The chronic subcohort includes 6000 patients with ACS, AS, AHF, or AKI 90 days after event, and patients with type 2 diabetes (T2DM) and target-organ damage. These patients undergo a 6-8 hour deep phenotyping program, including detailed clinical phenotyping from a cardiological, neurological and metabolic perspective, questionnaires including patient-reported outcome measures (PROMs)as well as magnetic resonance imaging. Several biological samples are collected (i.e. blood, urine, saliva, stool) with blood samples collected in a fasting state, as well as after a metabolic challenge (either nutritional or cardiopulmonary exercise stress test). Ascertainment of major adverse cardiovascular events (MACE) will be performed in all patients using a combination of active and passive follow-up procedures, such as on-site visits (if applicable), telephone interviews, review of medical charts, and links to local health authorities. Additional phenotyping visits are planned at 2, 5 and 10 years after inclusion into the chronic subcohort. Future perspective: BeLOVE provides a unique opportunity to study both the short- and long-term disease course of patients at high cardiovascular risk through innovative and extensive deep phenotyping. Moreover, the unique study design provides opportunities for acute and post-acute inclusion and allows us to derive two non-nested yet overlapping sub-cohorts, tailored for upcoming research questions. Thereby, we aim to study disease-overarching research questions, to understand crossover risk, and to find similarities and differences between clinical phenotypes of patients at high cardiovascular risk.


2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Basilio Pintaudi ◽  
Alessia Scatena ◽  
Gabriella Piscitelli ◽  
Vera Frison ◽  
Salvatore Corrao ◽  
...  

Abstract Background The European Society of Cardiology (ESC) recently defined cardiovascular risk classes for subjects with diabetes. Aim of this study was to explore the distribution of subjects with type 2 diabetes (T2D) by cardiovascular risk groups according to the ESC classification and to describe the quality indicators of care, with particular regard to cardiovascular risk factors. Methods The study is based on data extracted from electronic medical records of patients treated at the 258 Italian diabetes centers participating in the AMD Annals initiative. Patients with T2D were stratified by cardiovascular risk. General descriptive indicators, measures of intermediate outcomes, intensity/appropriateness of pharmacological treatment for diabetes and cardiovascular risk factors, presence of other complications and overall quality of care were evaluated. Results Overall, 473,740 subjects with type 2 diabetes (78.5% at very high cardiovascular risk, 20.9% at high risk and 0.6% at moderate risk) were evaluated. Among people with T2D at very high risk: 26.4% had retinopathy, 39.5% had albuminuria, 18.7% had a previous major cardiovascular event, 39.0% had organ damage, 89.1% had three or more risk factors. The use of DPP4-i markedly increased as cardiovascular risk increased. The prescription of secretagogues also increased and that of GLP1-RAs tended to increase. The use of SGLT2-i was still limited, and only slightly higher in subjects with very high cardiovascular risk. The overall quality of care, as summarized by the Q score, tended to be lower as the level of cardiovascular risk increased. Conclusions A large proportion of subjects with T2D is at high or very high risk. Glucose-lowering drug therapies seem not to be adequately used with respect to their potential advantages in terms of cardiovascular risk reduction. Several actions are necessary to improve the quality of care.


2021 ◽  
Vol 24 (1) ◽  
pp. 30
Author(s):  
Pintaudi, B.

AIM OF THE STUDY To explore the distribution by cardiovascular risk groups according to the classification promoted by the ESC (European Society of Cardiology) of subjects with type 1 (T1D) and type 2 (T2D) diabetes cared for by Italian diabetologists and to describe the quality indicators of care, with particular regard to cardiovascular risk factors. DESIGN AND METHODS The study is based on data extracted from electronic medical records of patients treated at the 258 diabetes centers participating in the Annals AMD initiative and active in the year 2018. Patients with T1D or T2D were stratified by cardiovascular risk, in accordance with the recent ESC guidelines. General descriptive indicators and measures of intermediate outcomes, intensity/appropriateness of pharmacological treatment for diabetes and cardiovascular risk factors, presence of other complications and overall quality of care were evaluated. RESULTS Overall, 29,368 adults with T1D and 473,740 subjects with T2D were evaluated. Among subjects with T1D: 64.7% were at very high cardiovascular risk, 28.5% at high risk and the remaining 6.8% at moderate risk. Among subjects with T1D at very high-risk: 54.7% had retinopathy, 29.0% had albuminuria, 7.3% had a history of major cardiovascular event, 47.3% had organ damage, 48.9% had three or more risk factors, and 70.6% had a diabetes duration of over 20 years. Among subjects with T2D: 78.5% were at very high cardiovascular risk, 20.9% at high risk and the remaining 0.6% at moderate risk. Among those with T2D at very high risk: 39.0% had organ damage, 89.1% had three or more risk factors, 18.7% had a previous major cardiovascular event, 26,4% had retinopathy, 39.5% had albuminuria. With regard to the glucose-lowering drugs: the use of DPPIV-i increased markedly as cardiovascular risk increased; the use of secretagogues also increased and, although within low percentages, also the use of GLP1-RA tended to increase. The use of SGLT2-i is also still limited, and only slightly higher in subjects with very high cardiovascular risk. In both types of diabetes, the overall quality of care, as summarized by the Q score values, tended to be lower as the level of cardiovascular riskincreased. CONCLUSIONS The analysis of a large population such as that of the AMD Annals database allowed to highlight the characteristics and quality indicators of care of subjects with T1D and T2D in relation to cardiovascular risk classes. A large proportion of subjects appear to be at high or very high risk. Glucose-lowering drug therapies seem not to be adequately used with respect to the potential advantages in terms of reduction of cardiovascular risk of some drug categories (GLP1-RA and SGLT2-i) and, conversely, with respect to the potential risks related to the use of other pharmacological classes (sulfonylureas). Several actions are necessary to optimize care and improve the quality of care for both subjects with T1D and T2D. KEY WORDS type 1 diabetes; type 2 diabetes; cardiovascular risk; quality indicators of care.


2018 ◽  
Vol 123 (3) ◽  
pp. 519-529 ◽  
Author(s):  
Geoffrey Hackett ◽  
Nigel Cole ◽  
Akhilesh Mulay ◽  
Richard C. Strange ◽  
Sudarshan Ramachandran

2021 ◽  
Vol 24 (2) ◽  
pp. 105
Author(s):  
Candido, R.

Type 2 diabetes mellitus is a progressive disease, associated with multiple cardiovascular risk factors (obesity, hypertension, dyslipidemia) and with the development of micro- and macro-vascular complications. Several anti-diabetic drugs commonly used, such as sulfonylureas, thiazolidinediones and insulin induce weight gain and have modest or negative effects on cardiovascular risk factors and cardiovascular events. In this context, the GLP-1 receptor agonists (GLP-1 RA) instead have an important action on glycemic control and β-cell dysfunction, show favorable effects on body weight, hypertension and lipid profile, have a reduced risk of hypoglycemia and more recently have demonstrated clear benefits on major cardiovascular events, cardiovascular mortality and renal damage. In these years it has been an evolution on the role of the GLP-1 RA in the new paradigm of type 2 diabetes. For this reason the GLP-1 RA find place at any moment of the cardiovascular and renal continuum, from the initial one for controlling blood glucose and the different risk factors to the most advanced when cardiovascular damage is already present. The GLP-1 RA therefore represent a key elements in the management of patients with type 2 diabetes at any time in the natural history of the disease both for glycemic control and for the prevention of CV and renal events. KEY WORDS GLP-1 receptor agonists; type 2 diabetes; cardiovascular risk factors; cardiovascular disease; cardiovascular outcome trials.


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