Exercise Hemodynamics in Patients With Pulmonary Fibrosis

Exercise Pulmonary Hypertension Clinical Trial

Official title:

Hemodynamic Study of the Pulmonary Circulation in Exercise in Patients With Pulmonary Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03706820
• Other study ID #: MED-AUTH-3.1/02-05-2018
• Status: Recruiting
• Start date: May 7, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: October 2018
• Source: Aristotle University Of Thessaloniki
• Contact: Evangelia S Panagiotidou, MD
• Phone: +306949139509
• Email: evangeliapanagiotidou[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 15, 2020
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Pulmonary Hypertension
• Hypertension, Pulmonary
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Greece	G.H. G. Papanikolaou	Thessaloniki	Asvestochori

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Herve P, Lau EM, Sitbon O, Savale L, Montani D, Godinas L, Lador F, Jaïs X, Parent F, Günther S, Humbert M, Simonneau G, Chemla D. Criteria for diagnosis of exercise pulmonary hypertension. Eur Respir J. 2015 Sep;46(3):728-37. doi: 10.1183/09031936.000219 — View Citation

Kovacs G, Herve P, Barbera JA, Chaouat A, Chemla D, Condliffe R, Garcia G, Grünig 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 Europea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total pulmonary resistance (TPR) from rest to exercise	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.	2nd minute,4th minute, 6th minute, 8th minute