Respiratory AmplitudeRESPIFLUXNCT04782531
Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers
A study testing peripheral ECG and Standard MRI in people with Respiratory Amplitude and Portal Blood Flow, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The analysis of portal vein blood flow is important when assessing the severity and progression of liver disease. It is important to understand normal liver regulation in order to appreciate the evaluation of the effect of treatment during the disease progression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Amplitude, Portal Blood Flow, MRI
- What is being tested?
- peripheral ECG and Standard MRI
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 7 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 ans
- Healthy subject without history of hepatic disease
Who cannot join
- history of hepatic pathology
- pregnant woman
- claustrophobia
- major obesity
- any contraindication to MRI exam
Trial locations and contacts
1 site in 1 country.
About this study
The analysis of portal vein blood flow is important when assessing the severity and progression of liver disease. It is important to understand normal liver regulation in order to appreciate the evaluation of the effect of treatment during the disease progression. The influence of respiration on hepatic hemodynamics is still poorly understood, although some studies have shown a significant impact. The purpose of this project is to quantify the blood flow variations in the portal vein at different positions during the respiratory cycle by using a fast MRI sequence and an Echo Planar (EPI) acquisition.
- Conditions
- Respiratory Amplitude, Portal Blood Flow, MRI, Echo Planar Imaging
- Being tested
- peripheral ECG, Standard MRI
- Keywords
- Respiratory amplitude, Portal Blood Flow, MRI, Echo Planar Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral ECGOther
Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.
Standard MRIOther
Standard MRI examination using a torso coil consists of morphological and phase-contrast flow sequences(standard and EPI acquisitions).
What is being measured
The primary outcome is the main question the study is designed to answer.
flow rates variation between the fast sequence averaged values and the standard sequence
flow rates variation between the fast sequence averaged values and the standard sequence during free breathing.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2023
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory AmplitudeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782531
- Sponsor's protocol ID
- PI2020_843_0150
- Acronym
- RESPIFLUX
- Status last verified
- May 2025
- First submitted
- 2 Mar 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04782531
- Acronym / sponsor ID
- RESPIFLUX / PI2020_843_0150
- Conditions
- Respiratory Amplitude, Portal Blood Flow, MRI, Echo Planar Imaging
- Keywords
- Respiratory amplitude, Portal Blood Flow, MRI, Echo Planar Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 4 Mar 2021 (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 analysis of portal vein blood flow is important when assessing the severity and progression of liver disease. It is important to understand normal liver regulation in order to appreciate the evaluation of the effect of treatment during the disease progression. The influence of respiration on hepatic hemodynamics is still poorly understood, although some studies have shown a significant impact. The purpose of this project is to quantify the blood flow variations in the portal vein at different positions during the respiratory cycle by using a fast MRI sequence and an Echo Planar (EPI) acquisition.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 ans
- Healthy subject without history of hepatic disease
Key exclusion criteria (5 listed)
- history of hepatic pathology
- pregnant woman
- claustrophobia
- major obesity
- any contraindication to MRI exam
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 |
|---|---|---|
| peripheral ECGSubjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate. | Other | – |
| Standard MRIStandard MRI examination using a torso coil consists of morphological and phase-contrast flow sequences(standard and EPI acquisitions). | Other | – |
Primary outcome
flow rates variation between the fast sequence averaged values and the standard sequence
Time frame: 30 minutes
flow rates variation between the fast sequence averaged values and the standard sequence during free breathing.
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 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral ECG and Standard MRI in people with Respiratory Amplitude and Portal Blood Flow, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 2 inclusion and 5 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 May 2025. 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 France. 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?
flow rates variation between the fast sequence averaged values and the standard sequence (time frame: 30 minutes). 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 May 2025.