NCT07254338: BREATH-TPT

Exploration of Metabolome in Patients With Interstitial Lung Disease and Pulmonary Hypertension With or Without Specific Pulmonary Hypertension Treatment

Recruiting now Last updated 17 February 2026

What this trial tests

trial testing Blood sampling for metabolomic profiling in Interstitial Lung Disease in 80 participants. Currently enrolling.

Timeline

16 February 2026

Primary endpoint
16 August 2029

16 August 2029

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	80
Start date	16 February 2026
Primary completion	16 August 2029
Estimated completion	16 August 2029
Sites	1 location across France

Drugs / interventions tested

• Blood sampling for metabolomic profiling
• Urine sampling for metabolomic profiling

Conditions studied

• Interstitial Lung Disease — all drugs for Interstitial Lung Disease →
• Precapillar Pulmonary Hypertension — all drugs for Precapillar Pulmonary Hypertension →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Interstitial Lung Disease or Precapillar Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fibrosing interstitial lung diseases (FILDs) encompass a group of rare diseases characterized by progressive pulmonary fibrosis leading to respiratory failure. Current treatments primarily aim to slow disease progression but remain limited, making lung transplantation the ultimate recourse.

The development of pulmonary hypertension (PH) in the context of FILDs significantly worsens morbidity and mortality and drastically reduces patients' life expectancy. Conventional treatments for PH are generally ineffective in this setting. Nevertheless, some promising therapeutic agents are currently under investigation, particularly inhaled prostacyclin analogs such as treprostinil, which have demonstrated efficacy in recent clinical studies.

Our study aims to explore, in a minimally invasive manner, variations in metabolites in the serum and urine of patients with PH secondary to FILDs, before and during treatment. The main objective is to better understand the systemic effect of these treatments. Furthermore, the identification of metabolomic signatures will allow us to differentiate responders from non-responders, thus providing valuable prognostic and predictive criteria.

To date, some patients do not benefit from the available treatments, and better selection of responders could prevent iatrogenic effects in patients whose clinical condition is already fragile. In addition, characterizing the systemic mode of action of these treatments could pave the way for new clinical research focused on the profiles of responding patients.

Finally, a thorough understanding of the efficacy of the studied therapies is essential. Indeed, effective treatment of PH in the context of FILDs could not only slow disease progression but also reduce the need for lung transplantation, a major challenge in a context of organ shortage.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.