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New Biomarkers in Heart- and Renal Failure (IM19 Register)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
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.

Condition or disease
Heart Failure Kidney Failure

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. Survival after recording on the intermediate care station [ Time Frame: 35 days ]

Secondary Outcome Measures :
  1. Survival after recording on the intermediate care station [ Time Frame: 12 months ]
  2. Major adverse cardiac events [ Time Frame: 12 months ]
  3. Rehospitalisation due to cardiovascular cause [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Included are patients with cardiac diseases and acute hospital admission:

  • NSTEMI myocardial infarction = non ST-segment elevation: unstable AP / heart attack with rise of Troponin I or T, but without ST track elevation
  • STEMI = ST-segment-elevation myocardial infarction: cardiac troponin T/where to sleep and enzyme changes and attack typical ECG changes (initial ST Elevation)
  • Acute heart failure with need of hospitalisation
  • Chronic heart failure decompensation and need to the hospitalisation and need for establishing primary > 12 hours on the station IM19 (conservative intermediate care station)
Criteria

Inclusion Criteria:

  1. at least 18 years old
  2. signed informed consent
  3. persons who are legally competent and mentally able to follow the instructions of study personnel
  4. Patient with:

    • NSTEMI myocardial infarction = non ST-segment elevation: unstable Angina pectoris (AP) / heart attack with rise of Troponin I or T, but without ST track elevation
    • STEMI = ST-segment-elevation myocardial infarction: cardiac troponin T/where to sleep and enzyme changes and attack typical ECG changes (initial ST Elevation)
    • Acute heart failure with need of hospitalisation
    • Chronic heart failure decompensation and need to the hospitalisation and need for establishing primary > 12 hours on the station IM19 (conservative intermediate care station)

Exclusion Criteria:

  1. less than 18 years old
  2. pregnant women and breastfeeding women
  3. previous recording on an intensive care unit or transfer to an intensive care unit within 12 h after admission the IM19 station
  4. death within 12 h after admission
  5. persons who are housed on official or judicial order in an institution
  6. persons who are in a dependency or employment relationship to the sponsor or investigator
  7. chronic dialysis patients
  8. persons , who at the same time take part in another study

Information from the National Library of Medicine

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


Contacts
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Contact: Alexander Schuh, Priv.-Doz. Dr.med. +49 241 80 36265 aschuh@ukaachen.de
Contact: Vincent Brandenburg Brandenburg, Prof. Dr. med. +49 241 80 85709 vbrandenburg@ukaachen.de

Locations
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Germany
University Hospital RWTH Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Alexander Schuh, Priv. - Doz. Dr. med.    +49 241 80 36265    aschuh@ukaachen.de   
Contact: Vincent Brandenburg, Prof. Dr. med.    +49 241 80 85709    vbrandenburg@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Alexander Schuh, Priv.-Doz. Dr.med. University Hospital RWTH Aachen

Publications:

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02830464    
Other Study ID Numbers: 15-151
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases