NCT07385482

Brief Summary

Very old patients are a rapidly growing and vulnerable population in acute cardiovascular care but remain underrepresented in clinical trials. Clinical outcomes in older intensive care unit (ICU) patients are determined less by chronological age than by their clinical phenotype, including cardiovascular comorbidities, frailty, polypharmacy, and functional and cognitive impairment. This prospective multicenter observational study aims to assess the impact of chronic and acute cardiovascular diseases on long-term outcomes and functional trajectories in older ICU patients. Using the international VIP research network, approximately 4,000 patients will be enrolled across different ICU specialties and healthcare systems and assessed multidimensionally using validated clinical scores. The study seeks to improve risk stratification and outcome prediction in older critically ill patients with cardiovascular disease and to address existing evidence gaps in acute cardiovascular and intensive care medicine.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress19%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

January 20, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

January 20, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

older intensive care patientsintensive care unitcardiovascular diseasefrailtymultimorbiditymortalityfunctional outcomehealth-related quality of life

Outcome Measures

Primary Outcomes (1)

  • mortality

    surivival or death

    within 6 months

Secondary Outcomes (4)

  • Functionality and Quality of Life

    6 months

  • Functionality and Quality of Life

    6 months

  • Functionality and Quality of Life

    6 months

  • Long-term survival and readmission rate

    up to 12 months

Other Outcomes (1)

  • The combined endpoint aims to evaluate both survival outcomes and functional independence

    6 months

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study focuses on older intensive care unit patients with chronic and acute cardiovascular diseases and is coordinated across multiple international sites using standardized data collection procedures.

You may qualify if:

  • years or older
  • Admission to the intensive care unit
  • Signed informed consent or absence of discernible indications suggesting the presumed intention of the patient not to participate in the study.

You may not qualify if:

  • \< 80 years
  • Absence of informed consent
  • Discernible indications suggesting the presumed intention of the patient not to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, Germany

Location

MeSH Terms

Conditions

FrailtyCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Malte Kelm, MD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

    STUDY CHAIR
  • Christian Jung, MD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 4, 2026

Study Start

March 1, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Locations