Metabolomics and Microbiomics in Cardiovascular Diseases
NCT ID: NCT04146701
Last Updated: 2021-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
750 participants
OBSERVATIONAL
2019-02-01
2022-12-31
Brief Summary
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Detailed Description
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The acute, critical or progressive disease status predestinies to relevant changes in cardiovascular metobolism. High-risk patients in the present trial comprise those with acute heart failure, myocardial infarction (STEMI and NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy with severely reduced left ventricular ejection fraction (LVEF \<35%).
Therfore this study investigates to identify disease-specific patterns of metabolic and microbiomic changes. These patterns may help to understand pathophysiology at the metabolic stages and find out those patients being at highest risk of adverse future outcome.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Acute heart failure
All consecutive patients admitted with acute heart failure to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Blood draw
venous blood withdraw (ca. 40ml)
STEMI
All consecutive patients admitted with STEMI to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Blood draw
venous blood withdraw (ca. 40ml)
NSTEMI
All consecutive patients admitted with NSTEMI to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Blood draw
venous blood withdraw (ca. 40ml)
Ischemic cardiomyopathy
All consecutive patients with an implantable cardioverter defibrillator (ICD) due to ischemic cardiomyopathy and LVEF \<35% presenting for ICD check-up to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Blood draw
venous blood withdraw (ca. 40ml)
Non-ischemic cardiomyopathy
All consecutive patients with an implantable cardioverter defibrillator (ICD) due to non-ischemic cardiomyopathy and LVEF \<35% presenting for ICD check-up to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Blood draw
venous blood withdraw (ca. 40ml)
Sepsis
All consecutive patients admitted with sepsis or septic shock to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Blood draw
venous blood withdraw (ca. 40ml)
Healthy controls
Clinically inapparent group as controls. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Blood draw
venous blood withdraw (ca. 40ml)
Interventions
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Blood draw
venous blood withdraw (ca. 40ml)
Eligibility Criteria
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Inclusion Criteria
* written informed consent
Exclusion Criteria
* cancer
* rheumatic diseases
* infections (except septic group)
* higher grade heart valve diseases
18 Years
100 Years
ALL
Yes
Sponsors
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Universitätsmedizin Mannheim
OTHER
Responsible Party
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Michael Behnes
Attending physician, adjunct professor
Principal Investigators
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Michael Behnes, PD Dr.
Role: STUDY_DIRECTOR
University Medical Center Mannheim
Locations
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University Medical Center Mannheim
Mannheim, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-1093N-MA
Identifier Type: -
Identifier Source: org_study_id
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