NCT06354426

Brief Summary

Data on the use of sequential organ failure assessment (SOFA) in patients with cardiovascular disease are increasing. Several studies demonstrated that the SOFA score can identify short-term mortality in patients with acute decompensated heart failure (ADHF). This study was conducted to determine the prognostic value of the admission SOFA score in patients hospitalised for ADHF and to assess its ability in predicting the 30-day readmission rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

March 30, 2024

Last Update Submit

April 5, 2024

Conditions

Keywords

SOFA scoreAcute decompensated heart failure

Outcome Measures

Primary Outcomes (1)

  • Mortality

    The sequential organ failure assessment (SOFA) score was used to assess the relation to the all cause mortality of the patient with acute decompensated heart failure. Higher SOFA score is correlated with higher in-hospital mortality rate and 30-day mortality regardless of age, gender, or other comorbidities.

    Within 30 days from the day of hospitalization

Secondary Outcomes (1)

  • Re-admission rate

    Within 30 days

Eligibility Criteria

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

This was a single-centre, prospective study conducted from July 2022 to August 2023 at Hanoi Heart Hospital (Hanoi, Vietnam).

You may qualify if:

  • All patients over 18 years old who were hospitalised for acute heart failure were included (either new-onset acute heart failure or ADHF).

You may not qualify if:

  • Patients with septic shock or pulmonary infarction were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanoi Heart Hospital

Hanoi, Hoan Kiem, 110000, Vietnam

Location

Study Design

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

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 9, 2024

Study Start

July 1, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations