Heart DiseasesNCT03232671
Role of Macrophage Migration Inhibitory Factor (MIF) in Heart Failure
An observational study of Heart Diseases, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in cardiovascular diseases when assessed in clinical routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- MIF ELISA
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to 1 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting with symptoms of heart failure.
Who may be able to join
- All patients presenting with symptoms of heart failure to the West-German Heart and Vascular Center according to the definition of the ESC 2016.
- Patients fulfilling criteria for the diagnosis of HFrEF
- Patients fulfilling criteria for the diagnosis of HFpEF
- Patients fulfilling criteria for the diagnosis of HFmrEF
- Patients presenting with dyspnea according to the NYHA classification I-IV, elevated BNP/NT-proBNP levels and echocardiographic findings of heart failure.
Who cannot join
- Age < 18 years
- Patients with symptoms of heart failure without fulfilling the criteria of the ESC guidelines 2016
- Denial to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Essen
Essen, North Rhine-Westphalia, 45147
About this study
Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in cardiovascular diseases when assessed in clinical routine.
- Conditions
- Heart Diseases
- Being tested
- MIF ELISA
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIF ELISADiagnostic test
Blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
180 days mortality
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study startMar 2016
- Primary completionApr 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadi Al-Rashid, University Hospital, Essen
- Investigators
- Peter Lüdike, M.D., Principal investigator, University Hospital of Essen, Department of Cardiology and Vascular medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232671
- Sponsor's protocol ID
- 15-6529-BO
- Status last verified
- Nov 2022
- First submitted
- 25 Jul 2017
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luedike P, Alatzides G, Papathanasiou M, Heisler M, Pohl J, Lehmann N, Rassaf T. Predictive potential of macrophage migration inhibitory factor (MIF) in patients with heart failure with preserved ejection fraction (HFpEF). Eur J Med Res. 2018 May 4;23(1):22. doi: 10.1186/s40001-018-0321-1.
PubMed 29728137
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Macrophage Migration Inhibitory Factor (MIF) in Heart Failure
- ClinicalTrials.gov ID
- NCT03232671
- Acronym / sponsor ID
- 15-6529-BO
- Conditions
- Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 28 Jul 2017 (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.
Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in cardiovascular diseases when assessed in clinical routine.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with symptoms of heart failure.
Key inclusion criteria (5 listed)
- All patients presenting with symptoms of heart failure to the West-German Heart and Vascular Center according to the definition of the ESC 2016.
- Patients fulfilling criteria for the diagnosis of HFrEF
- Patients fulfilling criteria for the diagnosis of HFpEF
- Patients fulfilling criteria for the diagnosis of HFmrEF
- Patients presenting with dyspnea according to the NYHA classification I-IV, elevated BNP/NT-proBNP levels and echocardiographic findings of heart failure.
Key exclusion criteria (3 listed)
- Age < 18 years
- Patients with symptoms of heart failure without fulfilling the criteria of the ESC guidelines 2016
- Denial to participate
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 |
|---|---|---|
| MIF ELISABlood sample | Diagnostic test | – |
Primary outcome
180 days mortality
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 29728137Luedike P, Alatzides G, Papathanasiou M, Heisler M, Pohl J, Lehmann N, Rassaf T. Predictive potential of macrophage migration inhibitory factor (MIF) in patients with heart failure with preserved ejection fraction (HFpEF). Eur J Med Res. 2018 May 4;23(1):22. doi: 10.1186/s40001-018-0321-1.
- Individual participant dataSharing planned: No
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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.
Peter Lüdike, M.D. principal investigator
University Hospital of Essen, Department of Cardiology and Vascular medicine
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 Heart Diseases, run by University Hospital, Essen 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 4 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
180 days mortality (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03232671, which also lists 1 linked publication.
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 4 Nov 2022.