Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE (MIRACLE)

March 31, 2026 updated by: University Heart Center Freiburg - Bad Krozingen
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bad Krozingen, Germany, 79189
      • Freiburg im Breisgau, Germany, 79106
      • Nuremberg, Germany
        • Active, not recruiting
        • Department for Internal Medicine 8, Clinic for Cardiology and Rhythmology, University Clinic of the Paracelsus Medi-cal University Nuremberg
      • Villingen-Schwenningen, Germany
        • Recruiting
        • Schwarzwald Baar Klinikum Villingen-Schwenningen, Klinik für Kardiologie und Intensivmedizin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult patients hospitalized at participating study sites with acute heart failure and cardiogenic shock (SCAI stages B-E).

Description

Inclusion Criteria:

  • Patients hospitalized with acute heart failure SCAI stage B - E.

Exclusion Criteria:

  • Not capable of providing informed consent due to reasons not attributable to cardiogenic shock
  • Cardiogenic shock following cardiothoracic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Arm 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 6 and 12 months
6 and 12 months
Rehospitalization for heart failure
Time Frame: From hospital discharge until 12 months
From hospital discharge until 12 months
Rehospitalization for cardiac reasons (non-elective)
Time Frame: From hospital discharge until 12 months
From hospital discharge until 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding ≥ SHARC 3a
Time Frame: Index hospitalization
Index hospitalization
Functional capacity (physical)
Time Frame: At 6 months follow up
Six-minute walk test
At 6 months follow up
Functional capacity (cognitive)
Time Frame: At 6 months follow up
MOCA
At 6 months follow up
Functional capacity
Time Frame: At 6 months follow up
KCCQ
At 6 months follow up
Quality of life measure
Time Frame: At 6 months follow up
PHQ-2
At 6 months follow up
Quality of life measure
Time Frame: At 6 months follow up
EQ-5D-5L
At 6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Heart Center Freiburg - Bad Krozingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-1041_1-S1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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