Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)

NCT04484298 | Completed DMC

• 1 other identifier: DYVIC2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

the study aimed to evaluate the diagnostic performance of cardiac output (CO) change after the use of trinitrine in the diagnosis of heart failure patients with acute dyspnea.

Conditions

Heart Failure

Keywords

dyspnea; acute; heart failure; bio-impedance; biopac system

Outcome Measures

Primary Outcomes (3)

• Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups

  the diagnostic performance is evaluated by calculating the CO in ml/min by bio-impedance technique and compare the values between patients with and without AHF and between baseline.

  24 hours

• roc curve

  Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the deltaCO.

  24

• Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.

  Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.

  24 hours

Study Arms (2)

reference group

EXPERIMENTAL

patients presenting to the emergency department with acute onset dyspnea are assessed for acute heart failure using the bio impedance technology (BIOPAC system) to measure the cardiac output in different clinical situations. FIRST: the cardiac output (CO) is measured at the reference position. Inbetween each step the patient was put in the reference position during 5 minutes.

Diagnostic Test: Reference position patient is put in a 30 degree supine position during 5 minutes

TRINITRINE

EXPERIMENTAL

0.6 mg of nitroglycerin was given to the patient sublingual and we measure the cardiac output by BIOPAC system(0.6 mg of Nitroglycerin was administered sublingually and CO was evaluated.

Diagnostic Test: nitroglucerin

Interventions

Reference position patient is put in a 30 degree supine position during 5 minutes DIAGNOSTIC_TEST

Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO)

reference group

nitroglucerin DIAGNOSTIC_TEST

0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.

TRINITRINE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old or above non traumatic acute dyspnea

You may not qualify if:

• ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours,
• pericardial effusion ,
• chest wall deformity suspected of causing dyspnea,
• coma,
• need for mechanical ventilation or vasopressor drugs,
• serious and sustained arrhythmia,
• pace maker,
• severe mitral valve disease, severe pulmonary arterial hypertension,
• renal failure (creatinine \>350µmol/l.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Emergency department of fattouma bourguiba university hospital

Monastir, 5020, Tunisia

Location

MeSH Terms

Conditions

Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• nouira semir, MD

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor semir nouira

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: January 2, 2019
• Primary Completion: February 29, 2020
• Study Completion: March 1, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)