Hemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- patient addressed for right heart catheterization for pulmonary hypertension suspicion or follow-up.

Exclusion Criteria:

- 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) - 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06079151
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	ADIR Association
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Elise ARTAUD-MACARI, MD
Principal Investigator Affiliation	ADIR Association
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension

Arms & Interventions

Arms

Experimental: Nasal high-flow 30 L/min and then 50 L/min

The patient will be placed successively under nasal high-flow 30 L/min during 20 min and then 50 L/min during 20 min.

Experimental: Nasal high-flow 50 L/min and then 30 L/min

The patient will be placed successively under nasal high-flow 50 L/min during 20 min and then 30 L/min during 20 min.

Interventions

Device: - Nasal high-flow

Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen if necessary

Contact a Trial Team

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