Acute Heart FailureMEMORIANCT04146701
Metabolomics and Microbiomics in Cardiovascular Diseases
An observational study of Acute Heart Failure and NSTEMI - Non-ST Segment Elevation MI, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
"MEtabolomics and MicrObiomics in caRdIovAscular diseases Mannheim (MEMORIAM) " is a single-center, prospective and observational study investigating to identify disease-specific metabolic, respectively microbiomic, patterns of patients with high-risk cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Blood draw
- How many people
- 750 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2019to 31 Dec 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffering from acute cardiovascular diseases such as acute heart failure, STEMI, NSTEMI, ischemic and dilative cardiomyopathies and sepsis.
Who may be able to join
- above mentioned diseases, diagnosis according to respective guideline
- written informed consent
Who cannot join
- under 18 years
- cancer
- rheumatic diseases
- infections (except septic group)
- higher grade heart valve diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Mannheim
Mannheim, 68167
Akin Ibrahim, Prof. Dr., 0049 621 383 5229, ibrahim.akin@umm.de
About this study
"MEtabolomics and MicrObiomics in caRdIovAscular diseases Mannheim (MEMORIAM) " is a single-center, prospective and observational study investigating to identify disease-specific metabolic, respectively microbiomic, patterns of patients with high-risk cardiovascular diseases. High-risk cardiovascular diseases comprise patients suffering from acute heart failure (AHF), ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy.
Read the detailed description
Scientific evidence about the metabolomic and microbiomic changes in high-risk cardiovascular patients is still lacking.
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
- Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, Myocardial Infarction, Acute, Sepsis, Cardiomyopathies
- Being tested
- Blood draw
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Myocardial Infarction, Sepsis, Cardiomyopathies, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
venous blood withdraw (ca. 40ml)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood draw | |
| 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. Receives: Other: Blood draw | |
| 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. Receives: Other: Blood draw | |
| 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. Receives: Other: Blood draw | |
| 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. Receives: Other: Blood draw | |
| 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. Receives: Other: Blood draw | |
| Healthy controls | Clinically inapparent group as controls. One venous blood withdraw will be performed. Demographic and clinical data will be documented. Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific metabolic/microbiomic biomarker patterns.
Expression of disease-specific metabolic/microbiomic biomarker patterns at the time of acute disease presentation
Measured: Within 24h after disease onset
Secondary outcomes (2)
All-cause and cardiovascular mortality.
All-cause and cardiovascular mortality, at 6 months and 12 months
Measured: 12 months after inclusion
Cardiac rehospitalization.
Cardiac rehospitalization, at 6 months and 12 months.
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Behnes, Universitätsmedizin Mannheim
- Investigators
- Michael Behnes, PD Dr., Study director, University Medical Center Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146701
- Sponsor's protocol ID
- 2019-1093N-MA
- Acronym
- MEMORIA
- Status last verified
- Feb 2021
- First submitted
- 29 Oct 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics and Microbiomics in Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT04146701
- Acronym / sponsor ID
- MEMORIA / 2019-1093N-MA
- Conditions
- Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, Myocardial Infarction, Acute, Sepsis, Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"MEtabolomics and MicrObiomics in caRdIovAscular diseases Mannheim (MEMORIAM) " is a single-center, prospective and observational study investigating to identify disease-specific metabolic, respectively microbiomic, patterns of patients with high-risk cardiovascular diseases. High-risk cardiovascular diseases comprise patients suffering from acute heart failure (AHF), ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy.
Detailed description
Scientific evidence about the metabolomic and microbiomic changes in high-risk cardiovascular patients is still lacking.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Acute heart failure | – | Other: Blood drawAll 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. |
| STEMI | – | Other: Blood drawAll consecutive patients admitted with STEMI to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented. |
| NSTEMI | – | Other: Blood drawAll consecutive patients admitted with NSTEMI to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented. |
| Ischemic cardiomyopathy | – | Other: Blood drawAll 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. |
| Non-ischemic cardiomyopathy | – | Other: Blood drawAll 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. |
| Sepsis | – | Other: Blood drawAll 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. |
| Healthy controls | – | Other: Blood drawClinically inapparent group as controls. One venous blood withdraw will be performed. Demographic and clinical data will be documented. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from acute cardiovascular diseases such as acute heart failure, STEMI, NSTEMI, ischemic and dilative cardiomyopathies and sepsis.
Key inclusion criteria (2 listed)
- above mentioned diseases, diagnosis according to respective guideline
- written informed consent
Key exclusion criteria (5 listed)
- under 18 years
- cancer
- rheumatic diseases
- infections (except septic group)
- higher grade heart valve diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawvenous blood withdraw (ca. 40ml) | Other | Acute heart failure, Healthy controls, Ischemic cardiomyopathy, NSTEMI, Non-ischemic cardiomyopathy, STEMI, Sepsis |
Primary outcome
Disease-specific metabolic/microbiomic biomarker patterns.
Time frame: Within 24h after disease onset
Expression of disease-specific metabolic/microbiomic biomarker patterns at the time of acute disease presentation
2 secondary outcomes
All-cause and cardiovascular mortality.
Time frame: 12 months after inclusion
Cardiac rehospitalization.
Time frame: 12 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
Related trials for Acute Heart Failure
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
RecruitingObservational study
Exploratory Study on Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Behnes, PD Dr. study director
University Medical Center Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure and NSTEMI - Non-ST Segment Elevation MI, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Behnes, PD Dr. (0049 621 383 6239, michael.behnes@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-specific metabolic/microbiomic biomarker patterns. (time frame: Within 24h after disease onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.