Heart FailureSenseIR-ICNCT06014593
Heart Failure Diagnostic Performance of an Expirogram Analysis Algorithm Evaluating 4 Biomarkers
A study testing expirogram in people with Heart Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Telemonitoring is a key clinical issue in heart failure (HF). Bedside measurement systems using handheld devices provide "digital biomarkers" useful for remote monitoring. A recent systematic review and meta-analysis showed that teleconsultations and telemonitoring at home improved the prognosis of HF patients… Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- expirogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2024to 31 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 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 25 to 85,
- Stable or worsening heart failure, diagnosed by a cardiologist,
- Patients requiring respiratory function tests and cardiac explorations as part of a work-up at Montpellier University Hospital (pre-cardiac transplant, pre-rehabilitation, pre-surgery, etc....).
Who cannot join
- Subject in a period of relative exclusion in relation to another protocol, or for whom the maximum annual indemnity of €6000 has been reached.
- Adult protected by law (guardianship, curatorship or safeguard of justice)
- Subject participating in another interventional research protocol
- Subject not affiliated to a social security scheme or not benefiting from such a scheme.
- Pregnant or breast-feeding woman, patient unable to give consent, protected adult, vulnerable persons (art.L. 1121-6, L. 1121-7, L. 1211-8, L. 1211-9 of the french legislation).
- Subject deprived of liberty by judicial or administrative decision
Show all 10Show fewer
- Subject having refused to give consent
- Healthy Volunteers :
- Age from 25 to 85,
- Volunteers with no previous cardiorespiratory history or treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Diagnostic Performance of an Algorithm for Analyzing Expirograms of 4 Biomarkers in Exhaled Air in Patients With Heart Failure
Telemonitoring is a key clinical issue in heart failure (HF). Bedside measurement systems using handheld devices provide "digital biomarkers" useful for remote monitoring. A recent systematic review and meta-analysis showed that teleconsultations and telemonitoring at home improved the prognosis of HF patients compared with usual care. Biomarkers contained in exhaled air could constitute "digital biomarkers" in HF, as measurement is non-invasive, and 4 different species have shown their potential interest: NO, CO, acetone and isoprene. The assessment of these species in the exhaled air to remains an issue in the perspective of non-invasive biomarkers in HF. Indeed, it requires selective sensors with low limit of detection. In addition, these sensors should be miniaturizable. Quartz-enhanced photoacoustic spectroscopy (QEPAS) are sensors that are suitable in this context. Last, the measured concentration should be informative and directly related to the HF. However, the concentration each of these biomarkers is not homogeneous during the expiration as it reflects the different lung compartments. While the end-expiratory concentration constitutes a sample of the alveolar concentration (AC) that reflects the blood concentration (BC) of one specie, the relationship between alveolar and blood concentrations is complex as exchanges that take place within these different compartments. Thus, measuring the concentration of a specie in exhaled air during a complete exhalation (or "expirogram") depends not only on the BC of the specie, but also on changes in lung function. Because both BC and changes in lung function depend on the severity of the HF, obtaining a full expirogram each specie should provide valid diagnosis information in HF. The mathematical modelization of real-time QEPAS sensors based expirograms together with lung function parameters (volume, flow) and lung compartment identification (capnography i.e. exhaled CO2 concentration) could provide valid algorithms with a an acceptable diagnosis performance in HF.
Read the detailed description
In the context of chronic diseases and heart failure (HF) in particular, telemedicine and telemonitoring have emerged as major clinical challenges today. The development of point-of-care measurement systems using hand-held devices provides "digital biomarkers" that are a key element in remote monitoring.
Biomarkers contained in exhaled air could constitute "digital biomarkers", as the measurement of molecules in exhaled air is non-invasive. Currently, 6 exhaled biomarkers are validated by the US FDA and used in a clinical context. In heart failure, 4 different species have been shown to be of potential diagnostic or prognostic interest: NO, CO, acetone and isoprene. However, while the concentration of these species in alveolar air (CA) reflects their blood concentration (Cs), the relationship is more complex, having to take into account the different compartments of the bronchial tree and the exchanges that take place within these different compartments. Thus, measuring the concentration of a species in exhaled air during a complete exhalation (or "expirogram") using a real-time measurement, turns out to be dependent not only on the systemic concentration of the species, but also on changes in lung function.Thus, obtaining an expirogram not only makes it possible to specify the measurement of the endogenous source of the species, but also provides information on changes in pulmonary function, directly induced by heart failure, and which have a well-recognized prognostic value.
→ The combination of different candidate exhaled biomarkers in IC, during a real-time measurement of forced expiration, using selective, sensitive and miniaturizable sensors would provide diagnostic, prognostic and patient outcome information in heart failure.
Quartz-enhanced photoacoustic spectroscopy (QEPAS) is a suitable method for remote monitoring of heart failure patients. It enables the creation of sensors characterized by good selectivity and low detection thresholds. What's more, real-time analysis is possible, and the sensors are potentially miniaturizable. These sensors are therefore capable of providing expirograms for different species (rather than simply measuring CA at the end of expiration). Complex signals of this type can be analyzed using mathematical modeling and artificial intelligence techniques such as "deep neural networks". These mathematical modelling methods have been used to model pulmonary, neurological or cardiac function parameters.
As part of a translational research project in collaboration with Dr. A. Vicet (MCF- UM, Institut d'Electronique et des Systèmes) and Prof. N. Molinari (CHRU Montpellier, Institut Desbrest d'Épidémiologie et de Santé Publique), the research team is currently developing sensors for various exhaled biomarkers using the QEPAS method, which have been coupled with synchronous quantification of volumes, flows and lung compartments. These sensors are currently undergoing analytical validation (in the laboratory). The first expirograms have been obtained and modelled using a spline regression dimension reduction method.
- Conditions
- Heart Failure
- Being tested
- expirogram
- Keywords
- heart failure, exhaled air biomarkers, sensors
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expirogramDevice
Recovery of heart failure data (left ventricular ejection fraction LVEF on cardiac echography (in mL), VO²max during, maximal cardio-pulmonary exercise test, plethysmographic spirometry, carbon monoxide transfer, NT-ProBNP assay,), clinical examination and finally expirogram with the device measuring the 4 exhaled biomarkers (CO/NO/Acetone/Isoprene).
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients | Other | Stable or relapsing heart failure patients aged between 25 and 85, diagnosed by a cardiologist and requiring respiratory and cardiac investigations at the Montpellier University Hospital. Receives: Device: expirogram |
| Healthy voluntary | Other | Volunteers Aged 25 to 85 with no previous cardiorespiratory history or treatment. Receives: Device: expirogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled CO
Pattern of exhaled CO, concentration during the full expiration (in ppmv)
Measured: Baseline
Secondary outcomes (3)
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled NO
Patterns of exhaled NO concentration during the full expiration (in ppmv)
Measured: Baseline
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled acetone
Patterns of exhaled acetone concentration during the full expiration (in ppmv)
Measured: Baseline
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled isoprene
Patterns of exhaled isoprene concentration during the full expiration (in ppmv)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start26 Apr 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Why it stopped: The early termination of this research is due to administrative and financial reasons. As the funding ends on 31/12/2024, we had to close the SenseIR-IC study in order to start the analyses before the end of the funding.
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.
- More trials run by University Hospital, MontpellierThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The device will be tested to measure biomarkers in a group of 55 Heart Failure patients and 20 healthy subjects.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Fares GOUZI, MD, Study director, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014593
- Sponsor's protocol ID
- RECHMPL23_0003
- Acronym
- SenseIR-IC
- Status last verified
- Jan 2025
- First submitted
- 11 Aug 2023
- Last updated
- 4 Feb 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Performance of an Algorithm for Analyzing Expirograms of 4 Biomarkers in Exhaled Air in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06014593
- Acronym / sponsor ID
- SenseIR-IC / RECHMPL23_0003
- Conditions
- Heart Failure
- Keywords
- heart failure, exhaled air biomarkers, sensors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The early termination of this research is due to administrative and financial reasons. As the funding ends on 31/12/2024, we had to close the SenseIR-IC study in order to start the analyses before the end of the funding.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 28 Aug 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.
Telemonitoring is a key clinical issue in heart failure (HF). Bedside measurement systems using handheld devices provide "digital biomarkers" useful for remote monitoring. A recent systematic review and meta-analysis showed that teleconsultations and telemonitoring at home improved the prognosis of HF patients compared with usual care. Biomarkers contained in exhaled air could constitute "digital biomarkers" in HF, as measurement is non-invasive, and 4 different species have shown their potential interest: NO, CO, acetone and isoprene. The assessment of these species in the exhaled air to remains an issue in the perspective of non-invasive biomarkers in HF. Indeed, it requires selective sensors with low limit of detection. In addition, these sensors should be miniaturizable. Quartz-enhanced photoacoustic spectroscopy (QEPAS) are sensors that are suitable in this context. Last, the measured concentration should be informative and directly related to the HF. However, the concentration each of these biomarkers is not homogeneous during the expiration as it reflects the different lung compartments. While the end-expiratory concentration constitutes a sample of the alveolar concentration (AC) that reflects the blood concentration (BC) of one specie, the relationship between alveolar and blood concentrations is complex as exchanges that take place within these different compartments. Thus, measuring the concentration of a specie in exhaled air during a complete exhalation (or "expirogram") depends not only on the BC of the specie, but also on changes in lung function. Because both BC and changes in lung function depend on the severity of the HF, obtaining a full expirogram each specie should provide valid diagnosis information in HF. The mathematical modelization of real-time QEPAS sensors based expirograms together with lung function parameters (volume, flow) and lung compartment identification (capnography i.e. exhaled CO2 concentration) could provide valid algorithms with a an acceptable diagnosis performance in HF.
Detailed description
In the context of chronic diseases and heart failure (HF) in particular, telemedicine and telemonitoring have emerged as major clinical challenges today. The development of point-of-care measurement systems using hand-held devices provides "digital biomarkers" that are a key element in remote monitoring.
Biomarkers contained in exhaled air could constitute "digital biomarkers", as the measurement of molecules in exhaled air is non-invasive. Currently, 6 exhaled biomarkers are validated by the US FDA and used in a clinical context. In heart failure, 4 different species have been shown to be of potential diagnostic or prognostic interest: NO, CO, acetone and isoprene. However, while the concentration of these species in alveolar air (CA) reflects their blood concentration (Cs), the relationship is more complex, having to take into account the different compartments of the bronchial tree and the exchanges that take place within these different compartments. Thus, measuring the concentration of a species in exhaled air during a complete exhalation (or "expirogram") using a real-time measurement, turns out to be dependent not only on the systemic concentration of the species, but also on changes in lung function.Thus, obtaining an expirogram not only makes it possible to specify the measurement of the endogenous source of the species, but also provides information on changes in pulmonary function, directly induced by heart failure, and which have a well-recognized prognostic value.
→ The combination of different candidate exhaled biomarkers in IC, during a real-time measurement of forced expiration, using selective, sensitive and miniaturizable sensors would provide diagnostic, prognostic and patient outcome information in heart failure.
Quartz-enhanced photoacoustic spectroscopy (QEPAS) is a suitable method for remote monitoring of heart failure patients. It enables the creation of sensors characterized by good selectivity and low detection thresholds. What's more, real-time analysis is possible, and the sensors are potentially miniaturizable. These sensors are therefore capable of providing expirograms for different species (rather than simply measuring CA at the end of expiration). Complex signals of this type can be analyzed using mathematical modeling and artificial intelligence techniques such as "deep neural networks". These mathematical modelling methods have been used to model pulmonary, neurological or cardiac function parameters.
As part of a translational research project in collaboration with Dr. A. Vicet (MCF- UM, Institut d'Electronique et des Systèmes) and Prof. N. Molinari (CHRU Montpellier, Institut Desbrest d'Épidémiologie et de Santé Publique), the research team is currently developing sensors for various exhaled biomarkers using the QEPAS method, which have been coupled with synchronous quantification of volumes, flows and lung compartments. These sensors are currently undergoing analytical validation (in the laboratory). The first expirograms have been obtained and modelled using a spline regression dimension reduction method.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The device will be tested to measure biomarkers in a group of 55 Heart Failure patients and 20 healthy subjects.
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients | Other | Device: expirogramStable or relapsing heart failure patients aged between 25 and 85, diagnosed by a cardiologist and requiring respiratory and cardiac investigations at the Montpellier University Hospital. |
| Healthy voluntary | Other | Device: expirogramVolunteers Aged 25 to 85 with no previous cardiorespiratory history or treatment. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 25 to 85,
- Stable or worsening heart failure, diagnosed by a cardiologist,
- Patients requiring respiratory function tests and cardiac explorations as part of a work-up at Montpellier University Hospital (pre-cardiac transplant, pre-rehabilitation, pre-surgery, etc....).
Key exclusion criteria (10 listed)
- Subject in a period of relative exclusion in relation to another protocol, or for whom the maximum annual indemnity of €6000 has been reached.
- Adult protected by law (guardianship, curatorship or safeguard of justice)
- Subject participating in another interventional research protocol
- Subject not affiliated to a social security scheme or not benefiting from such a scheme.
- Pregnant or breast-feeding woman, patient unable to give consent, protected adult, vulnerable persons (art.L. 1121-6, L. 1121-7, L. 1211-8, L. 1211-9 of the french legislation).
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 |
|---|---|---|
| expirogramRecovery of heart failure data (left ventricular ejection fraction LVEF on cardiac echography (in mL), VO²max during, maximal cardio-pulmonary exercise test, plethysmographic spirometry, carbon monoxide transfer, NT-ProBNP assay,), clinical examination and finally expirogram with the device measuring the 4 exhaled biomarkers (CO/NO/Acetone/Isoprene). | Device | Healthy voluntary, Heart failure patients |
Primary outcome
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled CO
Time frame: Baseline
Pattern of exhaled CO, concentration during the full expiration (in ppmv)
3 secondary outcomes
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled NO
Time frame: Baseline
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled acetone
Time frame: Baseline
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled isoprene
Time frame: Baseline
Results and safety
The study was stopped early (reason given: The early termination of this research is due to administrative and financial reasons. As the funding ends on 31/12/2024, we had to close the SenseIR-IC study in order to start the analyses before the end of the funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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.
Fares GOUZI, MD study director
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expirogram in people with Heart Failure, run by University Hospital, Montpellier 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 3 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: stopped early, as of the sponsor's last update on 4 Feb 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 was stopped early (reason given: The early termination of this research is due to administrative and financial reasons. As the funding ends on 31/12/2024, we had to close the SenseIR-IC study in order to start the analyses before the end of the funding.). Results are not available in the source record.
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?
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled CO (time frame: Baseline). 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 4 Feb 2025.