Heart Failure Diagnostic Performance of an Expirogram Analysis Algorithm Evaluating 4 Biomarkers (SenseIR-IC)

January 31, 2025 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Montpellier, France, 34000
        • CHU de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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....).

Exclusion Criteria:

  • 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
  • Subject having refused to give consent

Healthy Volunteers :

  • Age from 25 to 85,
  • Volunteers with no previous cardiorespiratory history or treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Heart failure patients
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.
Device: expirogram
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).
Other: Healthy voluntary
Volunteers Aged 25 to 85 with no previous cardiorespiratory history or treatment.
Device: expirogram
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled NO
Time Frame: Baseline
Patterns of exhaled NO concentration during the full expiration (in ppmv)
Baseline
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled acetone
Time Frame: Baseline
Patterns of exhaled acetone concentration during the full expiration (in ppmv)
Baseline
Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled isoprene
Time Frame: Baseline
Patterns of exhaled isoprene concentration during the full expiration (in ppmv)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Université Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fares GOUZI, MD, CHU de Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL23_0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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