Exercise Hemodynamics in Patients With Pulmonary Fibrosis

• Conditions: Exercise Pulmonary Hypertension

• Registration Number: NCT03706820
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2018-05-07
• Primary Completion: 2018-06-01
• Study First Submitted: 2018-09-29
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-11
• Study First Posted: 2018-10-16
• Last Update Posted: 2018-10-16
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total pulmonary resistance (TPR) from rest to exercise	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.

Trial Locations

Locations (1)

G.H. G. Papanikolaou; 🇬🇷 Thessaloniki, Asvestochori, Greece