NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
NCT04055428
Cardiovascular Diseases, Diabetes Mellitus
Birmingham, Alabama, United States
View Trial DetailsNCT Number: NCT04194372
Epidemiological studies are usually conducted in the general population in adults without complications or pathology at baseline. The results obtained are therefore often better designed for primary prevention use. The prediction of mortality risk in patients with complications and requiring hospital follow-up is less well known.
The study purpose is to determine a mortality risk profile in a hospital cohort of patients with pathologies associated with metabolic diseases.
Today the "multimaker" scores based on a panel of biomarkers - have significantly improved the discriminating power of prediction models existing in many pathologies. It is no longer a single biomarker that can improve risk prediction but a complete and cross-sectional profile that is sought after. We aim to establish a personalised mortality risk profile by combining clinical and biological parameters including metabolomics, genetics, transcriptomics and epigenomics by high throughput screening of biological samples.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ch Boulogne-Sur-Mer, Boulogne-sur-Mer, France
The prediction of the onset of diabetes and metabolic complications, especially cardiovascular, renal, or hepatic, is a major challenge to optimize the management of this disease.
Teams from the University Hospital of Lille have developed the Integra cohort study to identify the clinical and biological determinants of the occurrence of these complications and the mortality of patients with metabolic disorders.
The aim of the study is to identify clinico-biological determinants that are able to predict the occurence of death, cardiovascular events as well as hepatic or nephrotic one.
Follow-up data will be collected from National System of Health Data (SNDS) where data concerning hospitalisations, medical consultations and treatments are registered.
Biological samples are collected at baseline for a large OMICs analysis (metabolomics, genetics, transcriptomics and epigenomics) that would feed our predictive scoring system.
This project will allow us to describe new models of prediction of metabolic diseases and its complications, and to offer adapted and personalised methods of management, which can slow the progression of the disease and improve its prognosis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient also presenting a pathology among:
Exclusion criteria
Time frame: at 10 years
The number of patients dead according to national database
Time frame: at 10 years
composite criteria: cardiovascular death, myocardial infarction, stroke, coronary revascularization, peripheral revascularization, amputation)
Time frame: at 10 years
The number of patients that has been hospitalized for heart failure since the end of the study according to national database
Time frame: at 10 years
composite criteria: renal transplantation, dialysis, GFR >60, Albuminuria
Time frame: at 10 years
composite endpoint: hepatic fibrosis, cirrhosis, HCC, death from liver
Time frame: at 10 years
composite endpoint : CABG-related bleeding (Perioperative intracranial bleeding within 48 h / Reoperation after closure of sternotomy for the purpose of controlling bleeding / Transfusion of<5 U whole blood or packed red blood cells within a 48-hperiod / Chest tube output>=2L within a 24-h period)
or Fatal Bleeding (Probable fatal bleeding; no autopsy or imaging confirmation butclinically suspicious / Definite fatal bleeding; overt bleeding or autopsy or imagingconfirmation)
Contact information is provided by the study sponsor or research team.
University Hospital, Lille
Other
Acronym: INTEGRA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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