Exercise Hemodynamics in Patients With Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT03706820|
Recruitment Status : Unknown
Verified October 2018 by EVAGGELIA PANAGIOTIDOU, Aristotle University Of Thessaloniki.
Recruitment status was: Recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
|Condition or disease|
|Exercise Pulmonary Hypertension|
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:
- to evaluate the response of the hemodynamic parameters at exercise compared to the resting parameters in this patient group.
- to discriminate between precapillary from postcapillary etiology of pulmonary hypertension.
- to correlate non-invasive parameters of functional limitation with invasive hemodynamic parameters.
- to assess the prognostic role of exercise induced pulmonary hypertension in the specific patient group.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Hemodynamic Study of the Pulmonary Circulation in Exercise in Patients With Pulmonary Fibrosis|
|Actual Study Start Date :||May 7, 2018|
|Actual Primary Completion Date :||June 1, 2018|
|Estimated Study Completion Date :||December 15, 2020|
|normal rest and exercise hemodynamics|
|normal rest and abnormal exercise hemodynamics|
|resting pulmonary hypertension|
|abnormal wedge pressure at exercise|
- Change in total pulmonary resistance (TPR) from rest to exercise [ Time Frame: 2nd minute,4th minute, 6th minute, 8th minute ]The patient undergoes right heart catheterization and all hemodynamic variables are measured at rest and at exercise. TPR is derived by the following equation : mean pulmonary artery pressure/ cardiac output (mPAP/CO). TPR is measured at rest and at exercise following a specific protocol. The measurements are made at rest, then at the sequential exercise steps of increasing work resistance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706820
|Contact: Evangelia S Panagiotidou, MDemail@example.com|
|Contact: Georgia G Pitsiou, MD, PhDfirstname.lastname@example.org|
|G.H. G. Papanikolaou||Recruiting|
|Thessaloniki, Asvestochori, Greece, 57010|
|Contact: Evangelia S Panagiotidou, MD +306949139509 email@example.com|
|Study Chair:||Georgia G Pitsiou, MD, PhD||Aristotle University Of Thessaloniki|