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

October 25, 2022 updated by: RWTH Aachen University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • University Hospital RWTH Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival after recording on the intermediate care station
Time Frame: 35 days
35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac events
Time Frame: 12 months
12 months
Survival after recording on the intermediate care station
Time Frame: 12 months
12 months
Rehospitalisation due to cardiovascular cause
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Alexander Schuh, Priv.-Doz. Dr.med., University Hospital RWTH Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (ESTIMATE)

July 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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