NCT03831204

Brief Summary

The performance of STIs and clinical scores alone and their combination to predict short term prognosis of acute decompensated heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
642

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

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

February 20, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

2.4 years

First QC Date

July 6, 2018

Last Update Submit

July 17, 2020

Conditions

Keywords

impedancedyspneaAHFBNPEFFECTGWTG-HF

Outcome Measures

Primary Outcomes (1)

  • compare the STIs prognostic performance against clinical scores

    the area under ROC curve of the Systolic Time Intervals compared to the one of the EFFECT and GWTG HF scores

    30 days

Secondary Outcomes (1)

  • compare the STI prognostic performance between HFpEF and HFrEF patients

    30 days

Study Arms (2)

AHF/HFpEF

AHF with preserved ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient

Device: biopacDiagnostic Test: prognostic scores

AHF/HFrEF

AHF with reduced ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient

Device: biopacDiagnostic Test: prognostic scores

Interventions

biopacDEVICE

Acoustic cardiography was performed for all participants using the BIOPAC system with "Student Lab" software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus.

AHF/HFpEFAHF/HFrEF
prognostic scoresDIAGNOSTIC_TEST

Effect and GWTGHF were calculated for every patient

AHF/HFpEFAHF/HFrEF

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients aged more than 18 years admitted to the ED with the diagnosis of acute decompensated heart failure

You may qualify if:

  • non traumatic dyspnea
  • age more than 18 years old.

You may not qualify if:

  • ECG diagnostic for acute myocardial infarction
  • ischemic chest pain within the prior 24 hours
  • history of a heart transplant
  • pericardial effusion
  • chest wall deformity suspected of causing dyspnea
  • coma
  • shock,Mechanical Ventilation, vasopressor drugs
  • arrhythmia serious and sustained,
  • pace maker
  • severe mitral valve disease,
  • severe pulmonary arterial hypertension
  • renal failure with creatinine \>350micromol/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Monastir, 5000, Tunisia

Location

Related Links

MeSH Terms

Conditions

DyspneaHeart Failure

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Nouira Semir, Pr

    University hospital of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 6, 2018

First Posted

February 5, 2019

Study Start

February 20, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations