Acute Decompensated Heart FailureNCT05327374
Use of ΔIVC for Early Diagnosis of AHF in AECOPD
An observational study of Acute Decompensated Heart Failure and COPD Exacerbation, run by University of Monastir at 3 sites in Tunisia.
Trial summary
Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This association is frequently underestimated with regard to the difficulty of clinical diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Decompensated Heart Failure, COPD Exacerbation
- What is being tested?
- calculation of the inferior vena cava collapsibility index
- How many people
- 401 participants
- Where
- 3 sitesTunisia
- Study dates
- 1 Mar 2022to 31 Jan 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with history of COPD admitted to the emergency departmet for AECOPD and stable hemodynamic status
Who may be able to join
- patient with history of COPD and admitted to the emergency departement for AECOPD
Who cannot join
- impossibility to give consent to participate in the study, non consent patients
- post traumatic dyspnea
- instable hemodynamic or neurological status
Trial locations and contacts
3 sites in 1 country.
Tunisia3 sites
CHU Fattouma Bourguiba
Monastir, 5000
Emergency Departement
Monastir, 5000
Emergency department of fattouma bourguiba university hospital
Monastir, 5020
About this study
Official title: Diagnosis of Acute Heart Failure in Chronic Obstructive Pulmonary Disease Exacerbation Using the Inferior Vena Cava Collapsibilty Index
Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
This association is frequently underestimated with regard to the difficulty of clinical diagnosis.
The investigators expect that the application of the inferior vena cava collapsibility index (ΔIVC)could be useful in this issue.
Read the detailed description
Acute heart failure (AHF) is a common cause of COPD exacerbation however its role is very often underestimated. Until now, the use of echocardiography and some invasive hemodynamic exploration techniques such as the Swanganz catheter has been stated as reference. Other noninvasive diagnostic methods have been studied, such as systolic time intervals and Valsalva maneuver, but their application still difficult in patients with COPD exacerbation, especially in emergency department (ED) settings. the study aimed to evaluate the performance of a new diagnostic technique based on the measurement of the ΔIVC for the early identification of AHF in patients presenting to the ED with acute COPD exacerbation.
- Being tested
- calculation of the inferior vena cava collapsibility index
- Keywords
- COPD, Acute Heart Failure, Inferior vena cava, Ultrasound, Collapsibility index
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calculation of the inferior vena cava collapsibility indexDiagnostic test
the ΔIVC was calculated by the emergency physician who was blinded from the patient's medical history using the formula ((IVCmax-IVCmin)/IVCmax) X100.A cutoff of 15% was used to define the presence(<15%) or absence(>15%) of heart failure
| Study group | Role | What they receive |
|---|---|---|
| AHF-group | patients with AECOPD and acute heart failure Receives: Diagnostic Test: calculation of the inferior vena cava collapsibility index | |
| non AHF-group | patients with AECOPD without acute heart failure Receives: Diagnostic Test: calculation of the inferior vena cava collapsibility index |
What is being measured
The primary outcome is the main question the study is designed to answer.
the performance of ΔIVC in the diagnosis of acute heart failure
the accuracy of ΔIVC in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Mar 2022
- Primary completion30 Nov 2022
- Study completion31 Jan 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327374
- Sponsor's protocol ID
- ΔIVC /AHF/ AECOPD
- Status last verified
- May 2023
- First submitted
- 14 Mar 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Acute Heart Failure in Chronic Obstructive Pulmonary Disease Exacerbation Using the Inferior Vena Cava Collapsibilty Index
- ClinicalTrials.gov ID
- NCT05327374
- Acronym / sponsor ID
- ΔIVC /AHF/ AECOPD
- Keywords
- COPD, Acute Heart Failure, Inferior vena cava, Ultrasound, Collapsibility index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 14 Apr 2022 (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.
Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
This association is frequently underestimated with regard to the difficulty of clinical diagnosis.
The investigators expect that the application of the inferior vena cava collapsibility index (ΔIVC)could be useful in this issue.
Detailed description
Acute heart failure (AHF) is a common cause of COPD exacerbation however its role is very often underestimated. Until now, the use of echocardiography and some invasive hemodynamic exploration techniques such as the Swanganz catheter has been stated as reference. Other noninvasive diagnostic methods have been studied, such as systolic time intervals and Valsalva maneuver, but their application still difficult in patients with COPD exacerbation, especially in emergency department (ED) settings. the study aimed to evaluate the performance of a new diagnostic technique based on the measurement of the ΔIVC for the early identification of AHF in patients presenting to the ED with acute COPD exacerbation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AHF-group | – | Diagnostic Test: calculation of the inferior vena cava collapsibility indexpatients with AECOPD and acute heart failure |
| non AHF-group | – | Diagnostic Test: calculation of the inferior vena cava collapsibility indexpatients with AECOPD without acute heart failure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with history of COPD admitted to the emergency departmet for AECOPD and stable hemodynamic status
Key inclusion criteria (1 listed)
- patient with history of COPD and admitted to the emergency departement for AECOPD
Key exclusion criteria (3 listed)
- impossibility to give consent to participate in the study, non consent patients
- post traumatic dyspnea
- instable hemodynamic or neurological status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calculation of the inferior vena cava collapsibility indexthe ΔIVC was calculated by the emergency physician who was blinded from the patient's medical history using the formula ((IVCmax-IVCmin)/IVCmax) X100.A cutoff of 15% was used to define the presence(<15%) or absence(>15%) of heart failure | Diagnostic test | AHF-group, non AHF-group |
Primary outcome
the performance of ΔIVC in the diagnosis of acute heart failure
Time frame: 1 day
the accuracy of ΔIVC in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve
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 16 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Decompensated Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, 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)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
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
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.
Nouira Semir, Professor principal investigator
University of Monastir
3 sites 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 and COPD Exacerbation, run by University of Monastir at 3 sites in Tunisia.
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 3 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Tunisia. 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?
the performance of ΔIVC in the diagnosis of acute heart failure (time frame: 1 day). 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 16 May 2023.