NCT05327374

Brief 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. The investigators expect that the application of the inferior vena cava collapsibility index (ΔIVC)could be useful in this issue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

March 14, 2022

Last Update Submit

May 13, 2023

Conditions

Keywords

COPDAcute Heart FailureInferior vena cavaUltrasoundCollapsibility index

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day

Study Arms (2)

AHF-group

patients with AECOPD and acute heart failure

Diagnostic Test: calculation of the inferior vena cava collapsibility index

non AHF-group

patients with AECOPD without acute heart failure

Diagnostic Test: calculation of the inferior vena cava collapsibility index

Interventions

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

AHF-groupnon AHF-group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with history of COPD admitted to the emergency departmet for AECOPD and stable hemodynamic status

You may qualify if:

  • patient with history of COPD and admitted to the emergency departement for AECOPD

You may not qualify if:

  • impossibility to give consent to participate in the study, non consent patients
  • post traumatic dyspnea
  • instable hemodynamic or neurological status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

Emergency Departement

Monastir, 5000, Tunisia

Location

Emergency department of fattouma bourguiba university hospital

Monastir, 5020, Tunisia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nouira Semir, Professor

    University of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 14, 2022

Study Start

March 1, 2022

Primary Completion

November 30, 2022

Study Completion

January 31, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations