Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT03706820
Status:
UNKNOWN
Last Update Posted:
2018-10-16
First Post:
2018-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Hemodynamics in Patients With Pulmonary Fibrosis
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Study Overview
Official Title:
Hemodynamic Study of the Pulmonary Circulation in Exercise in Patients With Pulmonary Fibrosis
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: