Pulmonary HypertensionHighFlowHDNCT06079151
Hemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension
A study testing Nasal high-flow in people with Pulmonary Hypertension, run by ADIR Association at 1 site in France.
Trial summary
In this study, the investigators aim to describe the hemodynamic consequences of nasal high-flow measured during right heart catheterization and echocardiography. The research hypothesis is that nasal high-flow would increase cardiac output in patients with pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Nasal high-flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2024to 12 Feb 2026
- 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
- patient addressed for right heart catheterization for pulmonary hypertension suspicion or follow-up.
Who cannot join
- necessity of FiO2 >21% during right heart catheterization
- intracardiac shunt
- grade 4 tricuspid insufficiency
- complete arrhythmia due to atrial fibrillation
- Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception
- protected adult patient (tutorship or curatorship)
Show all 10Show fewer
- patient deprived of liberty by court or administrative decision
- refusal of patient participation or consent
- patient for whom the measurement of pulmonary arterial pressures during right heart catheterization is impossible
- patient for whom, during the etiological assessment of pulmonary hypertension, the diagnosis of precapillary pulmonary hypertension cannot be confirmed and classified in groups 1, 3 or 4.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ROUEN university hospital
Rouen, 76000
Elise Artaud-Macari, MD, eliseartaudmacari@yahoo.fr
About this study
Official title: Physiological Evaluation of the Hemodynamic Effects of Nasal High Flow in Patients Being Explored by Right Heart Catheterisation and Echocardiography for Suspected or Followed Precapillary Pulmonary Hypertension
In this study, the investigators aim to describe the hemodynamic consequences of nasal high-flow measured during right heart catheterization and echocardiography. The research hypothesis is that nasal high-flow would increase cardiac output in patients with pulmonary hypertension. The concomitant echocardiography will allow to describe its sensibility to detect cardiovascular consequences of nasal high-flow.
- Conditions
- Pulmonary Hypertension
- Being tested
- Nasal high-flow
- Keywords
- High-flow nasal cannula therapy, Hemodynamic monitoring, Echocardiography, right heart catheterization
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high-flowDevice
Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary
| Study group | Role | What they receive |
|---|---|---|
| Nasal high-flow 30 L/min and then 50 L/min | Experimental | The patient will be placed successively under nasal high-flow 30 L/min during 20 min and then 50 L/min during 20 min. Receives: Device: Nasal high-flow |
| Nasal high-flow 50 L/min and then 30 L/min | Experimental | The patient will be placed successively under nasal high-flow 50 L/min during 20 min and then 30 L/min during 20 min. Receives: Device: Nasal high-flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
Secondary outcomes (49)
cardiac output
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
cardiac output
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
Right atrial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
Right atrial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
Right atrial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
systolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
systolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
systolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
diastolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
diastolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
diastolic pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
mean pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
mean pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
mean pulmonary arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
capillary wedge pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
capillary wedge pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
capillary wedge pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
pulmonary vascular resistance
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
pulmonary vascular resistance
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
pulmonary vascular resistance
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
central venous oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
central venous oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
central venous oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
heart rate
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
heart rate
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
heart rate
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
systolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
systolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
systolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
diastolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
diastolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
diastolic arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
mean arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
mean arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
mean arterial pressure
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
systolic ejection volume
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
systolic ejection volume
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
systolic ejection volume
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
respiratory rate
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
respiratory rate
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
respiratory rate
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
pulse oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 50L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
pulse oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 30L/Min FiO2 21% as compared to room air
Measured: During the intervention, at isotime
pulse oxygen saturation
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
Measured: During the intervention, at isotime
Consequences of nasal high-flow 50 and 30 L/min FiO2 21% on echocardiographic parameters.
Cardiac output, inferior vena cava diameter and collapsibiliy, systolic pulmoanry arterial pressure, tricuspid regurgitation velocity,tricuspid annular plane systolic excursion, right ventricule strain, tricuspid S wave, right on left ventricular telediastolic surface ratio, left ventricular ejection fraction, mitral doppler, mitral S wave, respiratory variability of E mitral wave
Measured: During the intervention, at isotime
systolic pulmonary arterial pressure measured by catheterization and echocardiography.
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
Measured: During the intervention, at isotime
capillary wedge pressure measured by catheterization and echocardiography.
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
Measured: During the intervention, at isotime
right atrial pressure measured by catheterization and echocardiography.
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
Measured: During the intervention, at isotime
cardiac output measured by catheterization and echocardiography.
Concordance and correlation of hemodynamic parameters measured by catheterization and echocardiography.
Measured: During the intervention, at isotime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start13 Feb 2024
- Primary completion12 Feb 2026 (estimated)
- Study completion12 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All patients will be randomly allocated into two groups using the block randomization technique (4 or 8 according to an equiprobable distribution) in a 1:1 ratio. The randomisation will be performed at the begining of the catheterization procedure. In the first arm, the patient will successively receive 30 L/min then 50 L/min of room air. In the second arm, the patient will successively receive 50 L/min then 30 L/min of room air.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise ARTAUD-MACARI, MD, Principal investigator, ADIR Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079151
- Sponsor's protocol ID
- HighFlowHD
- Acronym
- HighFlowHD
- Status last verified
- Apr 2024
- First submitted
- 22 Aug 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Evaluation of the Hemodynamic Effects of Nasal High Flow in Patients Being Explored by Right Heart Catheterisation and Echocardiography for Suspected or Followed Precapillary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06079151
- Acronym / sponsor ID
- HighFlowHD / HighFlowHD
- Conditions
- Pulmonary Hypertension
- Keywords
- High-flow nasal cannula therapy, Hemodynamic monitoring, Echocardiography, right heart catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 12 Feb 2026 (estimated)
- Study completion
- 12 Feb 2026 (estimated)
- First posted
- 12 Oct 2023 (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.
In this study, the investigators aim to describe the hemodynamic consequences of nasal high-flow measured during right heart catheterization and echocardiography. The research hypothesis is that nasal high-flow would increase cardiac output in patients with pulmonary hypertension. The concomitant echocardiography will allow to describe its sensibility to detect cardiovascular consequences of nasal high-flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients will be randomly allocated into two groups using the block randomization technique (4 or 8 according to an equiprobable distribution) in a 1:1 ratio. The randomisation will be performed at the begining of the catheterization procedure. In the first arm, the patient will successively receive 30 L/min then 50 L/min of room air. In the second arm, the patient will successively receive 50 L/min then 30 L/min of room air.
| Arm | Type | Receives |
|---|---|---|
| Nasal high-flow 30 L/min and then 50 L/min | Experimental | Device: Nasal high-flowThe patient will be placed successively under nasal high-flow 30 L/min during 20 min and then 50 L/min during 20 min. |
| Nasal high-flow 50 L/min and then 30 L/min | Experimental | Device: Nasal high-flowThe patient will be placed successively under nasal high-flow 50 L/min during 20 min and then 30 L/min during 20 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient addressed for right heart catheterization for pulmonary hypertension suspicion or follow-up.
Key exclusion criteria (10 listed)
- necessity of FiO2 >21% during right heart catheterization
- intracardiac shunt
- grade 4 tricuspid insufficiency
- complete arrhythmia due to atrial fibrillation
- Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception
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 |
|---|---|---|
| Nasal high-flowNasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary | Device | Nasal high-flow 30 L/min and then 50 L/min, Nasal high-flow 50 L/min and then 30 L/min |
Primary outcome
Cardiac output
Time frame: During the intervention, at isotime
Changes measured during cardiac catheterization under nasal high-flow 30 and 50 L/min
49 secondary outcomes
cardiac output
Time frame: During the intervention, at isotime
cardiac output
Time frame: During the intervention, at isotime
Right atrial pressure
Time frame: During the intervention, at isotime
Right atrial pressure
Time frame: During the intervention, at isotime
Right atrial pressure
Time frame: During the intervention, at isotime
systolic pulmonary arterial pressure
Time frame: During the intervention, at isotime
systolic pulmonary arterial pressure
Time frame: During the intervention, at isotime
systolic pulmonary arterial pressure
Time frame: During the intervention, at isotime
diastolic pulmonary arterial pressure
Time frame: During the intervention, at isotime
diastolic pulmonary arterial pressure
Time frame: During the intervention, at isotime
diastolic pulmonary arterial pressure
Time frame: During the intervention, at isotime
mean pulmonary arterial pressure
Time frame: During the intervention, at isotime
mean pulmonary arterial pressure
Time frame: During the intervention, at isotime
mean pulmonary arterial pressure
Time frame: During the intervention, at isotime
capillary wedge pressure
Time frame: During the intervention, at isotime
capillary wedge pressure
Time frame: During the intervention, at isotime
capillary wedge pressure
Time frame: During the intervention, at isotime
pulmonary vascular resistance
Time frame: During the intervention, at isotime
pulmonary vascular resistance
Time frame: During the intervention, at isotime
pulmonary vascular resistance
Time frame: During the intervention, at isotime
central venous oxygen saturation
Time frame: During the intervention, at isotime
central venous oxygen saturation
Time frame: During the intervention, at isotime
central venous oxygen saturation
Time frame: During the intervention, at isotime
heart rate
Time frame: During the intervention, at isotime
heart rate
Time frame: During the intervention, at isotime
heart rate
Time frame: During the intervention, at isotime
systolic arterial pressure
Time frame: During the intervention, at isotime
systolic arterial pressure
Time frame: During the intervention, at isotime
systolic arterial pressure
Time frame: During the intervention, at isotime
diastolic arterial pressure
Time frame: During the intervention, at isotime
diastolic arterial pressure
Time frame: During the intervention, at isotime
diastolic arterial pressure
Time frame: During the intervention, at isotime
mean arterial pressure
Time frame: During the intervention, at isotime
mean arterial pressure
Time frame: During the intervention, at isotime
mean arterial pressure
Time frame: During the intervention, at isotime
systolic ejection volume
Time frame: During the intervention, at isotime
systolic ejection volume
Time frame: During the intervention, at isotime
systolic ejection volume
Time frame: During the intervention, at isotime
respiratory rate
Time frame: During the intervention, at isotime
respiratory rate
Time frame: During the intervention, at isotime
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Elise ARTAUD-MACARI, MD principal investigator
ADIR Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal high-flow in people with Pulmonary Hypertension, run by ADIR Association 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise ARTAUD-MACARI, MD (+33 2 32 88 59 92, elise.artaud-macari@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: During the intervention, at isotime). 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 19 Apr 2024.