- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07643610
BEAT-SHOCK Registry (BEAT-SHOCK)
June 8, 2026 updated by: University Hospital, Basel, Switzerland
BEAT-SHOCK (Basel Evaluation of Acute Therapy in Cardiogenic SHOCK) Registry
This regulation defines the purpose, the operational processes, and the organization of the registry BEAT-SHOCK (Basel Evaluation of Acute Therapy in cardiogenic SHOCK).
It describes the requirements for collecting, storing, processing, managing and sharing health-related registry data.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
8000
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
- Name: Jasper Boeddinghaus, PD Dr. med.
- Phone Number: 0041613287897
- Email: jasper.boeddinghaus@usb.ch
Study Contact Backup
- Name: Gregor Leibundgut, Prof. Dr.
- Phone Number: 0041613287897
- Email: gregor.leibundgut@usb.ch
Study Locations
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, Switzerland, 4031
- Recruiting
- University Hospital Basel
-
Principal Investigator:
- Jasper Boeddinghaus, PD Dr. med.
-
Contact:
- Jasper Boeddinghaus, PD Dr. med.
- Phone Number: 0041613287897
- Email: jasper.boeddinghaus@usb.ch
-
Contact:
- Gregor Leibundgut, Prof. Dr. med.
- Email: gregor.leibundgut@usb.ch
-
Principal Investigator:
- Gregor Leibundgut, Prof. Dr. med.
-
-
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
Adult patients who are treated at the University Hospital Basel and are diagnosed with cardiogenic shock, irrespective of underlying etiology or therapeutic strategy. The registry includes a wide range of cardiogenic shock etiologies, including:
- Myocardial infarction (MI)
- Fulminant myocarditis
- Acute decompensated heart failure
- Severe valvular disease
- Post-cardiotomy or perioperative cardiogenic shock
Description
- Patients admitted with cardiogenic shock to the University hospital Basel (diagnosis at the time of admission) or development of cardiogenic shock during the hospital stay
- Age ≥18 years
- Provision of written ICF
- Clinical diagnosis of cardiogenic shock.
- impaired organ perfusion due to primary cardiac dysfunction,
- persistent systolic blood pressure (SBP) <90 mmHg for ≥30 minutes, or the need for vasopressors, inotropes, or mechanical circulatory support (MCS) to maintain adequate perfusion and
- evidence of systemic hypoperfusion with arterial lactate ≥2 mmol/L or venous lactate ≥3 mmol/l and ≥1 of the following:
- Cold or clammy extremities
- Altered mental status
- Reduced urine output
- Signs of volume overload or congestion (on clinical exam, imaging, or invasive monitoring)
- Patients with normotensive cardiogenic shock (SBP ≥90 mmHg without vasopressors or MCS) may also be included if clear signs of hypoperfusion (arterial lactate ≥2 mmol/L or venous lactate ≥3 mmol/l) and cardiac dysfunction are present and alternative causes are excluded
Exclusion criteria:
- Age <18 years
- Refusal to provide informed consent by the patient or their legally authorized representative
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In-Hospital all-cause mortality occurring before discharge from the participating study centre
Time Frame: 10 years
|
In-hospital all-cause mortality is defined as death occurring before discharge from the participating study centre.
Deaths occurring after transfer to an external hospital are not counted as in-hospital deaths, but are captured through follow-up for 30-day and 90-day mortality.
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day and 90-day all-cause Mortality
Time Frame: 30, 90 days
|
30-day and 90-day all-cause mortality occuring after discharge from the participating study centre.
|
30, 90 days
|
|
Need for organ support at any time during hospitalization
Time Frame: 30, 60, 360 days
|
The need for organ support at any time during hospitalization (including renal replacement therapy, mechanical circulation support irrespective of type, and vasoactive or inotropic therapy)
|
30, 60, 360 days
|
|
Acute kidney injury (AKI) within 36 hours after index diagnosis of cardiogenic shock/index presentation
Time Frame: Within 36 hours after index diagnosis of cardiogenic shock/ index presentation.
|
Occurence of AKI (defined as an increase in serum creatinine of at least 26 µmol/L (0.3 mg/dL)
|
Within 36 hours after index diagnosis of cardiogenic shock/ index presentation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 1, 2025
Primary Completion (Estimated)
October 1, 2035
Study Completion (Estimated)
October 1, 2035
Study Registration Dates
First Submitted
May 29, 2026
First Submitted That Met QC Criteria
June 8, 2026
First Posted (Actual)
June 11, 2026
Study Record Updates
Last Update Posted (Actual)
June 11, 2026
Last Update Submitted That Met QC Criteria
June 8, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BEAT SHOCK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Not necessary, only data registry.
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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