Acute Decompensated Heart FailureNCT06354426
Short-term Mortality Prediction by the SOFA Score in Acute Decompensated Heart Failure
An observational study of Acute Decompensated Heart Failure, run by Hanoi Heart Hospital at 1 site in Vietnam.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- How many people
- 216 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jul 2022to 31 Aug 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: This was a single-centre, prospective study conducted from July 2022 to August 2023 at Hanoi Heart Hospital (Hanoi, Vietnam).
Who may be able to join
- All patients over 18 years old who were hospitalised for acute heart failure were included (either new-onset acute heart failure or ADHF).
Who cannot join
- Patients with septic shock or pulmonary infarction were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Mortality and Readmission Rate Prediction by the Sequential Organ Failure Assessment Score in Acute Decompensated Heart Failure
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.
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- SOFA score, Acute decompensated heart failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days from the day of hospitalization
Secondary outcomes (1)
Re-admission rate
To assess the prediction ability of the sequential organ failure assessment (SOFA) score in regard of re-admission rate.
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Jul 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hanoi Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354426
- Sponsor's protocol ID
- BVT2022/01
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Mortality and Readmission Rate Prediction by the Sequential Organ Failure Assessment Score in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT06354426
- Acronym / sponsor ID
- BVT2022/01
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- SOFA score, Acute decompensated heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Hanoi Heart HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This was a single-centre, prospective study conducted from July 2022 to August 2023 at Hanoi Heart Hospital (Hanoi, Vietnam).
Key inclusion criteria (1 listed)
- All patients over 18 years old who were hospitalised for acute heart failure were included (either new-onset acute heart failure or ADHF).
Key exclusion criteria (1 listed)
- Patients with septic shock or pulmonary infarction were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Within 30 days from the day of hospitalization
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.
1 secondary outcome
Re-admission rate
Time frame: Within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
Related trials for Acute Decompensated Heart Failure
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction
RecruitingPhase 3
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Heart Failure, Acute Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by Hanoi Heart Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Within 30 days from the day of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.