Heart Failure Diagnostic Performance of an Expirogram Analysis Algorithm Evaluating 4 Biomarkers

NCT06014593 | Terminated

• 1 other identifier: RECHMPL23_0003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Heart Failure

Keywords

heart failure; exhaled air biomarkers; sensors

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline

Secondary Outcomes (3)

• Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled NO

  Baseline

• Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled acetone

  Baseline

• Diagnostic performance (area under curve of ROC analysis) for the diagnosis of chronic heart failure of exhaled isoprene

  Baseline

Study Arms (2)

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.

Device: expirogram

Healthy voluntary

OTHER

Volunteers Aged 25 to 85 with no previous cardiorespiratory history or treatment.

Device: expirogram

Interventions

expirogram DEVICE

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).

Healthy voluntary; Heart failure patients

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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....).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator

Study Sites (1)

CHU de Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Fares GOUZI, MD

  CHU de Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The device will be tested to measure biomarkers in a group of 55 Heart Failure patients and 20 healthy subjects.

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 28, 2023
• Study Start: April 26, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)