No internvention in Acute Decompensated Heart Failure and Cardiogenic Shock and Myocardial Infarction (MI) - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Other: no internvention

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

Switzerland
- 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.

Sponsor

University Hospital, Basel, Switzerland

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)