New Biomarkers in Heart- and Renal Failure

Completed

• Conditions: Kidney Failure; Heart Failure

• Registration Number: NCT02830464
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Study Start: 2016-08
• Primary Completion: 2018-04
• Study Completion: 2018-06
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival after recording on the intermediate care station	35 days

Secondary Outcome Measures

Name	Time	Method
Survival after recording on the intermediate care station	12 months
Rehospitalisation due to cardiovascular cause	12 months
Major adverse cardiac events	12 months

Trial Locations

Locations (1)

University Hospital RWTH Aachen; 🇩🇪 Aachen, NRW, Germany