Clinical trial NCT03706820: Exercise Hemodynamics in Patients With Pulmonary Fibrosis
Official title: Hemodynamic Study of the Pulmonary Circulation in Exercise in Patients With Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exercise Pulmonary Hypertension
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are currently followed up in the Respiratory Clinics of the investigator's hospital and will be enrolled if suitable after having signed the form of consent.

Brief summary: The study evaluates the rest and exercise hemodynamics of patients presenting either idiopathic fibrotic pulmonary disease or pulmonary fibrosis secondary to connective tissue disease.

Detailed description: Patients with fibrotic pulmonary disease of the above origin will undergo detailed assessment of functional status with the following examinations: pulmonary function tests, echocardiogram, 6 minute exercise test, cardiopulmonary exercise test (in the absence of contra-indications) and finally right heart catheterization. Hemodynamic assessment will take place at rest and at exercise following the exercise protocol that was recommended by Herve et al (ERJ 2015) using a cycle ergometer at bedside.

The purposes of the study are:

1. to evaluate the response of the hemodynamic parameters at exercise compared to the resting parameters in this patient group.
2. to discriminate between precapillary from postcapillary etiology of pulmonary hypertension.
3. to correlate non-invasive parameters of functional limitation with invasive hemodynamic parameters.
4. to assess the prognostic role of exercise induced pulmonary hypertension in the specific patient group.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of pulmonary fibrosis secondary to connective tissue disease, according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) revised classification criteria , or diagnosis of idiopathic fibrotic diffuse pulmonary disease according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
2. Forced vital capacity (FVC) ≥ 40 %

Exclusion Criteria:

1. Presence of contra-indications to exercise tests, such as acute myocardial infarction, unstable angina, uncontrollable arrythmia or skeletal disease that limits the ability to exercise.
2. History of pulmonary embolism during the year before enrollment
3. Presence of severe valvular disease.
4. Current treatment with vasoactive drugs of the pulmonary circulation
5. Pulmonary wedge pressure (PAWP) at rest \> 15 mmHg

Primary outcomes:
measure: Change in total pulmonary resistance (TPR) from rest to exercise
timeFrame: 2nd minute,4th minute, 6th minute, 8th minute
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: G.H. G. Papanikolaou
state: Asvestochori
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Georgia G Pitsiou, MD, PhD
role: STUDY_CHAIR
References:
citation: Kovacs G, Herve P, Barbera JA, Chaouat A, Chemla D, Condliffe R, Garcia G, Grunig E, Howard L, Humbert M, Lau E, Laveneziana P, Lewis GD, Naeije R, Peacock A, Rosenkranz S, Saggar R, Ulrich S, Vizza D, Vonk Noordegraaf A, Olschewski H. An official European Respiratory Society statement: pulmonary haemodynamics during exercise. Eur Respir J. 2017 Nov 22;50(5):1700578. doi: 10.1183/13993003.00578-2017. Print 2017 Nov.
citation: Herve P, Lau EM, Sitbon O, Savale L, Montani D, Godinas L, Lador F, Jais X, Parent F, Gunther S, Humbert M, Simonneau G, Chemla D. Criteria for diagnosis of exercise pulmonary hypertension. Eur Respir J. 2015 Sep;46(3):728-37. doi: 10.1183/09031936.00021915. Epub 2015 May 28.
citation: Panagiotidou E, Betaoutou A, Fouka E, Papakosta D, Chatzopoulos E, Sourla E, Markopoulou A, Kioumis I, Stanopoulos I, Pitsiou G. Phenotyping exercise limitation of patients with Interstitial Fibrosing Lung Disease: the importance of exercise hemodynamics. Pulmonology. 2024 Mar-Apr;30(2):104-112. doi: 10.1016/j.pulmoe.2022.03.012. Epub 2022 May 11.