Systolic Time Intervals a Prognostic Tool of Heart Failure in Emergency Departement (STI/AHF)

Completed

• Conditions: Dyspnea; Heart Failure
• Interventions: Device: biopac; Diagnostic Test: prognostic scores

• Registration Number: NCT03831204
• Lead Sponsor: University of Monastir

Brief Summary

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

Detailed Description

Acute heart failure is a leading cause of hospitalization and death.Prediction of these adverse events is still challenging.

STI is an old technique based on the recording of two parameters: electrocardiogram and phonocardiogram, and from them measuring the different systolic intervals:

pre-ejection period (PEP),electro-mechanic activation time (EMAT), Left ventricular ejection time (LVET) and systolic time ratio (RTS) were measured.

The aim of these study is to demonstrate whether systolic time intervals (STIs) can improve clinical scores EFFECT (Enhanced Feedback for Effective Cardiac Treatment) and GWTG-HF (Get With the Guidelines-Heart Failure) for predicting 30 day mortality and readmission in patients with acute decompensated heart failure (ADHF) in the ED.

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2019-02-02
• Study First Posted: 2019-02-05
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 642

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AHF/HFrEF	prognostic scores	AHF with reduced ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient
AHF/HFpEF	biopac	AHF with preserved ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient
AHF/HFpEF	prognostic scores	AHF with preserved ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient
AHF/HFrEF	biopac	AHF with reduced ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient

Primary Outcome Measures

Name	Time	Method
compare the STIs prognostic performance against clinical scores	30 days	the area under ROC curve of the Systolic Time Intervals compared to the one of the EFFECT and GWTG HF scores

Secondary Outcome Measures

Name	Time	Method
compare the STI prognostic performance between HFpEF and HFrEF patients	30 days	compare the STI prognostic performance between HFpEF and HFrEF patients using the area under curve estimation of the ROC curve of the three systolic time intervals (PEP;EMAT measured in milliseconds,and PEP/EMAT) of the two groups

Trial Locations

Locations (1)

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia; 🇹🇳 Monastir, Tunisia