Pulmonary HypertensionPHREACTNCT03890627
Thoracic Bio-reactance Measurement of Cardiac Output in Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pulmonary Hypertension (PH) is a rare disease characterized by an increase in pulmonary vascular resistance, leading to a progressive decline in cardiac output (CO).Since cardiac output is correlated with the prognosis of the disease, the conduct of a right heart catheterization (thermodilution measurement, reference… 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?
- Thoracic bio-reactance
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2019to 31 May 2022
- Phase
- Observational
- 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
Study population: Adult patients with pulmonary hypertension and followed by a Competence Center.
Who may be able to join
- Aged over 18
- Presenting pulmonary hypertension (PH) followed by the Competence Center of the Hospices Civils de Lyon
- Follow-up for pulmonary hypertension groups 1, 4 or 5
- Of which the cardiac index is ≥ 2,5 L/min/m²
- Expressing its non-opposition to the participation of this study
- Benefiting from a social security scheme or similar
Who cannot join
- Adult patient protected by Law
- Patient for whom a thermodilution measurement of cardiac output (CO) is unreliable: right-left shunt; or uncorrected congenital heart disease; or variability> 10% of the 3 measurements of CO obtained by thermodilution
- pulmonary hypertension groups 2 or 3
- Hemodynamic aggravation since the previous visit: increased pressure or decreased cardiac index
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Explorations Fonctionnelles Respiratoires, centre de compétences de l'hypertension pulmonaire Hospices Civils de Lyon, Groupement Hospitalier Est
Bron, 69677
About this study
Official title: Interest of Cardiac Output Measurement by Thoracic Bio-reactance for Monitoring of Patients Treated for a Pulmonary Hypertension
Pulmonary Hypertension (PH) is a rare disease characterized by an increase in pulmonary vascular resistance, leading to a progressive decline in cardiac output (CO).Since cardiac output is correlated with the prognosis of the disease, the conduct of a right heart catheterization (thermodilution measurement, reference technique) during the annual follow-up visit of patients in competences centres is recommended. In practice, it is not systematically performed because of it is invasive, with potential risk for the patient, and there is limited logistical capacity for its implementation. The estimation of cardiac output is thus often based on cardiac ultrasound but its measurement is potentially biased.
Starling ™ SV is a non-invasive cardiac output monitor based on thoracic bio-reactance measurement. Several clinical studies have shown that cardiac output measured by bio-reactance is strongly correlated with the measurement obtained by catheterization in different indications. Rich et al. (2013) assessed bio-reactance specifically in 50 patients with Pulmonary Hypertension compared with thermodilution. The results showed that the measurement of cardiac output by bio-reactance was feasible in these patients, had a better accuracy than by catheterization, and was reliable for detecting changes in cardiac output after a vasodilatation test.
The Starling ™ SV monitor could thus have a place in the follow-up of patients who are being treated for Pulmonary Hypertension. Since it is a rapid, non-invasive examination, it could be performed on an outpatient basis, especially as a first-line test to check the stability of the CO, thus avoiding the systematic use of right heart catheterization, which would then be reserved only to patients for whom the measurement by bio-reactance would show a decrease of cardiac output compared to the previous value. Before being able to propose this use in current practice, it is necessary to carry out a pilot study which will make it possible to explore the interest of bio-reactance in this situation.
- Conditions
- Pulmonary Hypertension
- Being tested
- Thoracic bio-reactance
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic bio-reactanceDevice
Cardiac output variation measured by thoracic bio-reactance, between inclusion and one year after hemodynamic evaluation by right cardiac catheterization, to discriminate stable patients from those that degrade.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic bio-reactance measurement of cardiac output | Not described Receives: Device: Thoracic bio-reactance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the relative variation of cardiac output measured by thoracic bio-reactance to predict the patient's status (stable or unstable).
A patient will be considered unstable if the decrease in the relative variation of cardiac output measured with thermodilution between visit one and one year after visit one is at least 15%. Then, the ability of the relative variation of cardiac output measured by thoracic bio-reactance to predict the patient's status (stable or unstable) will be assessed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start21 May 2019
- Primary completion31 May 2022
- Study completion31 May 2022
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.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890627
- Sponsor's protocol ID
- 69HCL18_0819
- Acronym
- PHREACT
- Status last verified
- Oct 2022
- First submitted
- 25 Mar 2019
- Last updated
- 13 Oct 2022
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Cardiac Output Measurement by Thoracic Bio-reactance for Monitoring of Patients Treated for a Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03890627
- Acronym / sponsor ID
- PHREACT / 69HCL18_0819
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 26 Mar 2019 (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.
Pulmonary Hypertension (PH) is a rare disease characterized by an increase in pulmonary vascular resistance, leading to a progressive decline in cardiac output (CO).Since cardiac output is correlated with the prognosis of the disease, the conduct of a right heart catheterization (thermodilution measurement, reference technique) during the annual follow-up visit of patients in competences centres is recommended. In practice, it is not systematically performed because of it is invasive, with potential risk for the patient, and there is limited logistical capacity for its implementation. The estimation of cardiac output is thus often based on cardiac ultrasound but its measurement is potentially biased.
Starling ™ SV is a non-invasive cardiac output monitor based on thoracic bio-reactance measurement. Several clinical studies have shown that cardiac output measured by bio-reactance is strongly correlated with the measurement obtained by catheterization in different indications. Rich et al. (2013) assessed bio-reactance specifically in 50 patients with Pulmonary Hypertension compared with thermodilution. The results showed that the measurement of cardiac output by bio-reactance was feasible in these patients, had a better accuracy than by catheterization, and was reliable for detecting changes in cardiac output after a vasodilatation test.
The Starling ™ SV monitor could thus have a place in the follow-up of patients who are being treated for Pulmonary Hypertension. Since it is a rapid, non-invasive examination, it could be performed on an outpatient basis, especially as a first-line test to check the stability of the CO, thus avoiding the systematic use of right heart catheterization, which would then be reserved only to patients for whom the measurement by bio-reactance would show a decrease of cardiac output compared to the previous value. Before being able to propose this use in current practice, it is necessary to carry out a pilot study which will make it possible to explore the interest of bio-reactance in this situation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic bio-reactance measurement of cardiac output | – | Device: Thoracic bio-reactance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with pulmonary hypertension and followed by a Competence Center.
Key inclusion criteria (6 listed)
- Aged over 18
- Presenting pulmonary hypertension (PH) followed by the Competence Center of the Hospices Civils de Lyon
- Follow-up for pulmonary hypertension groups 1, 4 or 5
- Of which the cardiac index is ≥ 2,5 L/min/m²
- Expressing its non-opposition to the participation of this study
Key exclusion criteria (4 listed)
- Adult patient protected by Law
- Patient for whom a thermodilution measurement of cardiac output (CO) is unreliable: right-left shunt; or uncorrected congenital heart disease; or variability> 10% of the 3 measurements of CO obtained by thermodilution
- pulmonary hypertension groups 2 or 3
- Hemodynamic aggravation since the previous visit: increased pressure or decreased cardiac index
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 |
|---|---|---|
| Thoracic bio-reactanceCardiac output variation measured by thoracic bio-reactance, between inclusion and one year after hemodynamic evaluation by right cardiac catheterization, to discriminate stable patients from those that degrade. | Device | Thoracic bio-reactance measurement of cardiac output |
Primary outcome
Ability of the relative variation of cardiac output measured by thoracic bio-reactance to predict the patient's status (stable or unstable).
Time frame: 12 months
A patient will be considered unstable if the decrease in the relative variation of cardiac output measured with thermodilution between visit one and one year after visit one is at least 15%. Then, the ability of the relative variation of cardiac output measured by thoracic bio-reactance to predict the patient's status (stable or unstable) will be assessed.
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 13 Oct 2022.
- 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?
An observational study of Pulmonary Hypertension, run by Hospices Civils de Lyon 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 6 inclusion and 4 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 13 Oct 2022. 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?
Ability of the relative variation of cardiac output measured by thoracic bio-reactance to predict the patient's status (stable or unstable). (time frame: 12 months). 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 13 Oct 2022.