Cardiogenic ShockMIRACLENCT07515508
Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE
An observational study of Cardiogenic Shock and Acute Heart Failure (AHF), run by University Heart Center Freiburg - Bad Krozingen at 4 sites in Germany.
Trial summary
The goal of this observational study is to learn whether information collected during routine hospital care, together with blood and urine samples, can help doctors better identify different types of cardiogenic shock and better predict outcomes in adults hospitalized with acute heart failure and cardiogenic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Acute Heart Failure (AHF)
- How many people
- 600 participants
- Where
- 4 sitesGermany
- Study dates
- 7 Aug 2024to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Consecutive adult patients hospitalized at participating study sites with acute heart failure and cardiogenic shock (SCAI stages B-E).
Who may be able to join
- Patients hospitalized with acute heart failure SCAI stage B - E.
Who cannot join
- Not capable of providing informed consent due to reasons not attributable to cardiogenic shock
- Cardiogenic shock following cardiothoracic surgery
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Recruiting
University Heart Center Freiburg - Bad Krozingen
Bad Krozingen, 79189
Adrian Heidenreich, MD, 004976334020, adrian.heidenreich@uniklinik-freiburg.de
- Recruiting
University Medical Center Freiburg, Interdisciplinary Medical Intensive Care
Freiburg im Breisgau, 79106
Annette Buellesbach, MD, 004976127033889, annette.buellesbach@uniklinik-freiburg.de
- Recruiting
Department for Internal Medicine 8, Clinic for Cardiology and Rhythmology, University Clinic of the Paracelsus Medi-cal University Nuremberg
Nuremberg
Tim Sternberg, MD, 0049911 3980, Tim.Sternberg@klinikum-nuernberg.de
- Recruiting
Schwarzwald Baar Klinikum Villingen-Schwenningen, Klinik für Kardiologie und Intensivmedizin
Villingen-Schwenningen
Sebastian Ewen, MD, 00497721 930, sebastian.ewen@sbk-vs.de
About this study
The goal of this observational study is to learn whether information collected during routine hospital care, together with blood and urine samples, can help doctors better identify different types of cardiogenic shock and better predict outcomes in adults hospitalized with acute heart failure and cardiogenic shock. The main question is whether clinical findings, imaging results, and biomarkers, including sex-specific factors, are associated with the risk of death within 30 days. Participants will not receive an experimental treatment. Researchers will collect data from routine care, collect additional blood and urine samples for biobanking, and follow participants after hospital discharge
- Conditions
- Cardiogenic Shock, Acute Heart Failure (AHF)
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days
Secondary outcomes (3)
Mortality
Measured: 6 and 12 months
Rehospitalization for heart failure
Measured: From hospital discharge until 12 months
Rehospitalization for cardiac reasons (non-elective)
Measured: From hospital discharge until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start7 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Heart Center Freiburg - Bad Krozingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515508
- Sponsor's protocol ID
- 24-1041_1-S1
- Acronym
- MIRACLE
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2026
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE
- ClinicalTrials.gov ID
- NCT07515508
- Acronym / sponsor ID
- MIRACLE / 24-1041_1-S1
- Conditions
- Cardiogenic Shock, Acute Heart Failure (AHF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Heart Center Freiburg - Bad KrozingenUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 7 Apr 2026 (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.
The goal of this observational study is to learn whether information collected during routine hospital care, together with blood and urine samples, can help doctors better identify different types of cardiogenic shock and better predict outcomes in adults hospitalized with acute heart failure and cardiogenic shock. The main question is whether clinical findings, imaging results, and biomarkers, including sex-specific factors, are associated with the risk of death within 30 days. Participants will not receive an experimental treatment. Researchers will collect data from routine care, collect additional blood and urine samples for biobanking, and follow participants after hospital discharge
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients hospitalized at participating study sites with acute heart failure and cardiogenic shock (SCAI stages B-E).
Key inclusion criteria (1 listed)
- Patients hospitalized with acute heart failure SCAI stage B - E.
Key exclusion criteria (2 listed)
- Not capable of providing informed consent due to reasons not attributable to cardiogenic shock
- Cardiogenic shock following cardiothoracic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30 days
3 secondary outcomes
Mortality
Time frame: 6 and 12 months
Rehospitalization for heart failure
Time frame: From hospital discharge until 12 months
Rehospitalization for cardiac reasons (non-elective)
Time frame: From hospital discharge until 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Acute Heart Failure (AHF), run by University Heart Center Freiburg - Bad Krozingen at 4 sites 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucas Bacmeister, MD (004976127034010, lucas.bacmeister@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). 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 29 Jul 2026.