Learn about Research & Clinical Trials

Exercise Hemodynamics in Patients With Pulmonary Fibrosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	20 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03706820
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aristotle University Of Thessaloniki
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Georgia G Pitsiou, MD, PhD
Principal Investigator Affiliation	Aristotle University Of Thessaloniki
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Greece
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Exercise Pulmonary Hypertension

Additional Details

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.

Arms & Interventions

Arms

: normal rest and exercise hemodynamics

: normal rest and abnormal exercise hemodynamics

: resting pulmonary hypertension

: abnormal wedge pressure at exercise

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.