ClinicalTrials.gov record NCT05727852

Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Exhaled Breath Proton Mass Spectrometry and Assessment of Endothelial Dysfunction in Patients With Respiratory Diseases

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.The registry record was last updated on Jul 30, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationRussia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study examines breath chemical profiles and noninvasive heart and artery tests in people with chronic respiratory diseases and in age- and sex-matched healthy adults. Participants provide a breath sample analyzed by proton-transfer reaction time-of-flight mass spectrometry and undergo one-lead ECG/pulse-wave recording and arterial stiffness measurement. Researchers will compare patterns to look for breath markers linked with ventilation or cardiovascular abnormalities.

What it is studying. The study tests whether exhaled volatile organic compound (eVOC) patterns measured by PTR-TOF mass spectrometry are associated with measures of endothelial dysfunction and arterial stiffness in people with different chronic respiratory diseases, and whether disease-specific eVOC markers can be identified for severe ventilation and cardiovascular disorders.

What the researchers hope to learn. To determine the diagnostic significance of PTR-TOF breath analysis and to identify exhaled volatile organic compound markers associated with severe ventilation and cardiovascular disorders in chronic respiratory diseases.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Assessment of cardiovascular disorders using echocardiography and arterial stiffness; comparative noninvasive assessment of volatile organic compound (eVOC) exhale breath patterns in patients with different chronic respiratory diseases with age and gender-matched healthy adults in order to identify a disease-specific exhaled eVOCs profiles and markers of respiratory and cardiovascular disorders.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • Breath test using the Compact PTR-TOF-MS
  • Portable cardiac monitor "CardioQvark"
  • Assessment of arterial stiffness using the VaSera VS-1500N

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Written informed consent to participate in the study;
  • Age 18 and over;
  • Clinical diagnosis of one of chronic respiratory diseases (COPD, bronchial asthma, cystic fibrosis, lymphangioleiomyomatosis, hypersensitivity pneumonitis or other interstitial lung disease).

Exclusion criteria

  • Unable to sign informed consent;
  • Respiratory disease (for controls);
  • Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis);
  • Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism within the last 3 months;
  • Oncology;
  • Previous lung transplantation (for patients with respiratory diseases);
  • Diseases and conditions that can change the ECG picture and complicate the analysis of the ECG (conduction disturbance, pacemaker);
  • Inability to use a heart monitor (congenital developmental anomalies, traumatic amputation of the upper limbs, essential tremor, Parkinson's disease);
  • Pregnancy.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Evaluating of eVOCs profiles by proton mass spectrometry with a time-of-flight (PTR-TOF) in patients with different chronic respiratory diseases is of great interest for assessing the prognosis and development of severe ventilation and cardiovascular disorders. The aim of our study is to determine the diagnostic significance of PTR-TOF analysis in patients with chronic respiratory diseases and to identify specific eVOC markers of a severe ventilation and cardiovascular disorders in patients with different chronic respiratory diseases.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will provide exhaled breath samples for analysis by proton mass spectrometry (PTR‑TOF‑MS). They will have a one‑lead ECG recorded once with a portable CardioQvark monitor (data are transferred in depersonalized form). They will undergo non‑invasive arterial stiffness testing with the VaSera VS‑1500N (blood pressure cuffs on four limbs with simultaneous ECG, phonocardiogram, and pulse‑wave recordings on carotid, femoral and limb arteries). The study may also collect standard respiratory tests and clinical data such as questionnaires, spirometry and other lung function tests, diffusion testing (DLCO), echocardiography, chest CT if needed, and sputum culture as listed in the registry.

How the study is structured. Observational, cross-sectional (case-crossover) study. Participants undergo one-time diagnostic tests only: a breath PTR-TOF mass spectrometry analysis, a portable one-lead ECG with pulse-wave assessment, and noninvasive arterial stiffness measurement; results are compared across disease groups and matched healthy controls.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says participants are enrolled by invitation. Who decides who is invited, and how?
  • The listed sites are in Russia. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on lymphangioleiomyomatosis

Clinical trials10 trials listed for lymphangioleiomyomatosisEvery trial the registry lists for lymphangioleiomyomatosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in lymphangioleiomyomatosis researchLatest monthly update: September 2026. Includes: Pleural fluid drainage. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 30, 2023
Primary completion
January 2025 (estimated)
Study completion
December 2026 (estimated)
Target enrollment
400 participants (estimated)
Last updated on registry
Jul 30, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
I.M. Sechenov First Moscow State Medical University

Participating sites (1)

  • I.M. Sechenov First Moscow State Medical University (Sechenov University), Center "Digital biodesign and personalized healthcare"

    Moscow, 119991 · Russia

Terms used on this page · explanations by MedicalUpdates.ai

echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
Written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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