Heart Failuredyvic2NCT04484298
Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)
A study testing Reference position patient is put in a 30 degree supine position during 5 minutes and nitroglucerin in people with Heart Failure, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Reference position patient is put in a 30 degree supine position during 5 minutes and nitroglucerin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2019to 1 Mar 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 year old or above non traumatic acute dyspnea
Who cannot join
- 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,
Show all 9Show fewer
- pace maker,
- severe mitral valve disease, severe pulmonary arterial hypertension,
- renal failure (creatinine >350µmol/l.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency department of fattouma bourguiba university hospital
Monastir, 5020
About this study
Official title: Dynamic Variation of Impedance Cardiography (ICG) a Diagnostic Tool of Acute Heart Failure (AHF) in Emergency Department (ED) Patients Admitted for Acute Dyspnea
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.
Read the detailed description
Acute heart failure (AHF) is a frequent condition in emergency department and is responsible of high number of admissions, complications, and deaths.
despite advances in diagnostic techniques, AHF diagnosis still be challenging .
Measurement of cardiac output (CO) is used to evaluate global cardiac function and changes in CO may be used to identify a change in the hemodynamic status of patient.
the gold standard of measuring CO is thermodilution catheterization, however it is an invasive technique with high risks.
Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by applying small electrical current to the chest through electrodes placed on the neck and sides.
the pulsatile flow of blood causes fluctuations in the current, and the device calculates CO from the impedance waveform.
In practice, the investigators connect the device "BIOPAC" by using four electrodes which the investigators place on the base of the neck (posterior face) and on the base of the thorax (posterior face).
The ECG recording is taken simultaneously with two other electrodes placed at the right upper limb and left lower limb.
In addition to detecting the electric current and the ECG, heart sounds are recorded using a sensor that is placed at the mitral site.
Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO). NTG (0.6 mg) is then given to the patient sublingually and CO measurement was repeated. CO is calculated by averaging three measurements at one minute intervals at baseline and after NTG administration. DeltaCO was defined as the percent of change of baseline CO after NTG test.
- Conditions
- Heart Failure
- Being tested
- Reference position patient is put in a 30 degree supine position during 5 minutes, nitroglucerin
- Keywords
- dyspnea, acute, heart failure, bio-impedance, biopac system
- Medical subject headings
- Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference position patient is put in a 30 degree supine position during 5 minutesDiagnostic test
Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO)
nitroglucerinDiagnostic test
0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: nitroglucerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
roc curve
Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the deltaCO.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start2 Jan 2019
- Primary completion29 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 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, MD, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484298
- Sponsor's protocol ID
- DYVIC2
- Acronym
- dyvic2
- Status last verified
- Mar 2021
- First submitted
- 20 Jul 2020
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Variation of Impedance Cardiography (ICG) a Diagnostic Tool of Acute Heart Failure (AHF) in Emergency Department (ED) Patients Admitted for Acute Dyspnea
- ClinicalTrials.gov ID
- NCT04484298
- Acronym / sponsor ID
- dyvic2 / DYVIC2
- Conditions
- Heart Failure
- Keywords
- dyspnea, acute, heart failure, bio-impedance, biopac system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 23 Jul 2020 (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.
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.
Detailed description
Acute heart failure (AHF) is a frequent condition in emergency department and is responsible of high number of admissions, complications, and deaths.
despite advances in diagnostic techniques, AHF diagnosis still be challenging .
Measurement of cardiac output (CO) is used to evaluate global cardiac function and changes in CO may be used to identify a change in the hemodynamic status of patient.
the gold standard of measuring CO is thermodilution catheterization, however it is an invasive technique with high risks.
Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by applying small electrical current to the chest through electrodes placed on the neck and sides.
the pulsatile flow of blood causes fluctuations in the current, and the device calculates CO from the impedance waveform.
In practice, the investigators connect the device "BIOPAC" by using four electrodes which the investigators place on the base of the neck (posterior face) and on the base of the thorax (posterior face).
The ECG recording is taken simultaneously with two other electrodes placed at the right upper limb and left lower limb.
In addition to detecting the electric current and the ECG, heart sounds are recorded using a sensor that is placed at the mitral site.
Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO). NTG (0.6 mg) is then given to the patient sublingually and CO measurement was repeated. CO is calculated by averaging three measurements at one minute intervals at baseline and after NTG administration. DeltaCO was defined as the percent of change of baseline CO after NTG test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reference group | Experimental | Diagnostic Test: Reference position patient is put in a 30 degree supine position during 5 minutespatients 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. |
| TRINITRINE | Experimental | Diagnostic Test: nitroglucerin0.6 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 year old or above non traumatic acute dyspnea
Key exclusion criteria (9 listed)
- 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,
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 |
|---|---|---|
| Reference position patient is put in a 30 degree supine position during 5 minutesEach patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO) | Diagnostic test | reference group |
| nitroglucerin0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated. | Diagnostic test | TRINITRINE |
Primary outcome
Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups
Time frame: 24 hours
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.
roc curve
Time frame: 24
Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the 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.
Time frame: 24 hours
Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.
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 29 Mar 2021.
- Individual participant dataSharing planned: No
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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, MD principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference position patient is put in a 30 degree supine position during 5 minutes and nitroglucerin in people with Heart Failure, run by University of Monastir at 1 site 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 9 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 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 29 Mar 2021.