NCT07508891

Brief Summary

An observational cohort study to evaluate the benefit of functional parameters, radiomics and blood biomarkers to predict the outcome of patients with acute heart failure.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Mar 2019Dec 2030

Study Start

First participant enrolled

March 1, 2019

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

11.8 years

First QC Date

December 30, 2025

Last Update Submit

March 30, 2026

Conditions

Acute Heart FailureDecompensated Heart FailureCardiogenic Shock

Keywords

cardiogenic shockacute heart failureheart failurebiomarkerbiobankcohort studyphenotypingrisk prediction

Outcome Measures

Primary Outcomes (1)

  • Time to cardiovascular death or first rehospitalisation for heart failure

    Etiologies of death and hospitalisation will be adjudicated by local investigators. Time-to-event analyses are planned for the primary outcome.

    from enrolment up to 5 years

Secondary Outcomes (9)

  • Incidence rate of cardiovascular death and total rehospitalisations for heart failure

    from enrolment up to 5 years

  • Time to cardiovascular death

    from enrolment up to 5 years

  • Time to first rehospitalisation for heart failure

    from enrolment up to 5 years

  • Incidence rate of total rehospitalisations for heart failure

    from enrolment up to 5 years

  • Incidence rate of progression of cardiogenic shock

    within index hospitalisation (enrolment to discharge or death)

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalised patients with acute heart failure of any aetiology and stage at a German tertiary care centre.

You may qualify if:

  • Clinical diagnosis of acute heart failure, including all stages of cardiogenic shock, de novo heart failure as well as decompensated chronic heart failure.
  • Hospitalisation due to acute heart failure or new-onset acute heart failure during a hospitalisation de to a different cause. Out-patients with acute heart failure are not included.

You may not qualify if:

  • Age \< 18 years
  • No written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (3)

  • Kriz M, Kellner C, Beer BN, Sundermeyer J, Dettling A, Besch L, Benesch Vidal ML, Becher N, Savarese G, Kirchhof P, Blankenberg S, Magnussen C, Schrage B, Becher PM. Early rhythm control in patients with acute decompensated heart failure: results from the CYCLE cohort study. Europace. 2025 Dec 1;27(12):euaf314. doi: 10.1093/europace/euaf314. No abstract available.

    PMID: 41342526RESULT

  • Beer BN, Keshtkaran S, Kellner C, Besch L, Sundermeyer J, Dettling A, Kirchhof P, Blankenberg S, Magnussen C, Schrage B. Pro-adrenomedullin associates with congestion in acute heart failure patients. ESC Heart Fail. 2024 Dec;11(6):3598-3606. doi: 10.1002/ehf2.15007. Epub 2024 Aug 20.

    PMID: 39161275RESULT

  • Beer BN, Kellner C, Sundermeyer J, Besch L, Dettling A, Kirchhof P, Blankenberg S, Magnussen C, Schrage B. Prediction of cardiac worsening through to cardiogenic shock in patients with acute heart failure. ESC Heart Fail. 2024 Aug;11(4):2249-2258. doi: 10.1002/ehf2.14792. Epub 2024 Apr 17.

    PMID: 38632837RESULT

Biospecimen

Retention: SAMPLES WITH DNA

* Blood (whole blood, serum, plasma (EDTA, citrated), DNA, RNA, washed erythrocytes) * Urine samples

MeSH Terms

Conditions

Shock, CardiogenicHeart Failure

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Central Study Contacts

Benedikt Schrage, MD, PhD

CONTACT

+49 40 7410 0b.schrage@uke.de

Christina Magnussen, MD

CONTACT

+49 40 7410 0c.magnussen@uke.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

April 2, 2026

Study Start

March 1, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

DE(1)