New Biomarkers in Heart- and Renal Failure (IM19 Register)
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|ClinicalTrials.gov Identifier: NCT02830464|
Recruitment Status : Unknown
Verified October 2017 by RWTH Aachen University.
Recruitment status was: Recruiting
First Posted : July 12, 2016
Last Update Posted : October 27, 2017
|Condition or disease|
|Heart Failure Kidney Failure|
In recent years advances in diagnosis/ therapy in patients with acute coronary syndromes heart failure / and renal insufficiency patients could be made. However, these diseases still associated with an increased mortality rate. The diseases affecting at the same time as the heart and the kidney contribute to the deterioration in the course of the disease. An acute or chronic functional impairment of an organ, e.g. the heart, is connected to another functional impairment, such as the kidneys. In the past, different scores to the risk and prognosis assessment have been introduced measuring many different diagnostic parameters such as E.g. age, pre-existing conditions, kidney function, heart function, and laboratory values. The scores can be used for risk assessment and treatment.
For determining the prognosis of heart and kidney-failure patients, biomarkers are analyzed. Biomarkers in the blood or urine which can provide early information on a specific course of disease are called prognostic biomarkers. In this study, prognostically relevant biomarkers for cardiovascular / renal insufficiencies will be clinically evaluated, to improve the course of assessment of such disease and to gain new insights into the typical course of congestive heart failure. This is a prerequisite to allow patients to appropriate treatment as soon as possible. An important role in heart and vascular disease can be awarded the Fibroblast growth factor 23 (FGF) 23. The height of FGF23 in the blood plasma is linked with the risk of cardiovascular events occur and the beginning of dialysis patients. FGF23 goes hand in hand with the development of heart failure or with a hospitalization as a result of heart failure.
The clinical utility of biomarkers will be examined in relation to established risk scores calculated from clinical parameters, to determine whether this biomarker of bone-heart-kidney axis can extend the forecast evaluation of patients.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||New Biomarkers in Heart- and Renal Failure: Cohort Study for Assessing Prognosis in Acute Coronary Syndrome and Acute/Chronic Cardiovascular and Renal Failure by Means of Fibroblast Growth Factor 23|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
- Survival after recording on the intermediate care station [ Time Frame: 35 days ]
- Survival after recording on the intermediate care station [ Time Frame: 12 months ]
- Major adverse cardiac events [ Time Frame: 12 months ]
- Rehospitalisation due to cardiovascular cause [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830464
|Contact: Alexander Schuh, Priv.-Doz. Dr.med.||+49 241 80 email@example.com|
|Contact: Vincent Brandenburg Brandenburg, Prof. Dr. med.||+49 241 80 firstname.lastname@example.org|
|Principal Investigator:||Alexander Schuh, Priv.-Doz. Dr.med.||University Hospital RWTH Aachen|