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Impact of Therapy Optimization on the Level of Biomarkers in Patients With Decompensated Heart Failure

NCT01501981 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2017-07-25

No results posted yet for this study

Summary

In this pilot, investigator-initiated multi-centre, multinational, observational study the investigators would like to examine the impact of therapy optimization on the level of biomarkers in patients with acute decompensated and decompensated chronic heart failure.

The primary objective is to determine the best time point for measuring biomarker levels during therapy optimization in patients with decompensation to predict clinical outcomes such as mortality, hospitalisation, and quality of life.

Secondary objectives are:

1. To evaluate the impact of guideline-recommended medication on biomarker levels during and following recompensation.
2. To evaluate whether the trajectory of relevant biomarkers (MR-proANP, MR-proADM) is of relevance to guide medical therapy following decompensation.
3. To evaluate whether the degree of biomarker change (e.g. slow versus rapid change) is of relevance with regard to hemodynamic stability and cardiovascular events such as hospitalisation.
4. To evaluate whether the trajectory of relevant biomarkers (copeptin, CT-pro-ET1) is of relevance to guide medical therapy following decompensation.

Conditions

  • Decompensated Heart Failure

Sponsors & Collaborators

  • Brahms AG

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01501981 on ClinicalTrials.gov