Multimodal Phenotyping In Patients Referred With Acute Ca... | NCT07515508

Studies
Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE

NCT07515508

Sponsor

University Heart Center Freiburg - Bad Krozingen

Status

Recruiting

Last Update Posted

Apr 7, 2026Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Cardiogenic Shock
Acute Heart Failure (AHF)

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 7, 2024Actual

Primary Completion Date

Jul 31, 2027Estimated

Completion Date

Jul 31, 2028Estimated

First Submitted Date

Mar 26, 2026

First Submission Date that Met QC Criteria

Mar 31, 2026

First Posted Date

Apr 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Label	Type	Description	Intervention Names
Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality		30 days

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Bleeding ≥ SHARC 3a		Index hospitalization
Functional capacity (physical)	Six-minute walk test	At 6 months follow up

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lucas Bacmeister, MD	Contact	004976127034010		lucas.bacmeister@uniklinik-freiburg.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Heart Center Freiburg - Bad Krozingen	Recruiting	Bad Krozingen		79189	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012770	Shock, Cardiogenic

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided