Exercise Hemodynamics in Patients With Pulmonary Fibrosis

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

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

Study Overview

• Status: Unknown
• Conditions: Exercise Pulmonary Hypertension

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Evangelia S Panagiotidou, MD; Phone Number: +306949139509; Email: evangeliapanagiotidou@gmail.com
• Study Contact Backup: Name: Georgia G Pitsiou, MD, PhD; Email: gpitsiou@yahoo.gr

Study Locations

• Greece
  • Asvestochori
    • Thessaloniki, Asvestochori, Greece, 57010
      • Recruiting
      • G.H. G. Papanikolaou
      • Contact: Evangelia S Panagiotidou, MD; Phone Number: +306949139509; Email: evangeliapanagiotidou@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients are currently followed up in the Respiratory Clinics of the investigator's hospital and will be enrolled if suitable after having signed the form of consent.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
normal rest and exercise hemodynamics
normal rest and abnormal exercise hemodynamics
resting pulmonary hypertension
abnormal wedge pressure at exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Study Chair: Georgia G Pitsiou, MD, PhD, Aristotle University Of Thessaloniki

Publications and helpful links

General Publications

• Kovacs G, Herve P, Barbera JA, Chaouat A, Chemla D, Condliffe R, Garcia G, Grunig 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 European Respiratory Society statement: pulmonary haemodynamics during exercise. Eur Respir J. 2017 Nov 22;50(5):1700578. doi: 10.1183/13993003.00578-2017. Print 2017 Nov. Erratum In: Eur Respir J. 2018 Jan 18;51(1):
• Herve P, Lau EM, Sitbon O, Savale L, Montani D, Godinas L, Lador F, Jais X, Parent F, Gunther S, Humbert M, Simonneau G, Chemla D. Criteria for diagnosis of exercise pulmonary hypertension. Eur Respir J. 2015 Sep;46(3):728-37. doi: 10.1183/09031936.00021915. Epub 2015 May 28.
• Panagiotidou E, Betaoutou A, Fouka E, Papakosta D, Chatzopoulos E, Sourla E, Markopoulou A, Kioumis I, Stanopoulos I, Pitsiou G. Phenotyping exercise limitation of patients with Interstitial Fibrosing Lung Disease: the importance of exercise hemodynamics. Pulmonology. 2022 May 11:S2531-0437(22)00105-2. doi: 10.1016/j.pulmoe.2022.03.012. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): June 1, 2018
• Study Completion (Anticipated): December 15, 2020

Study Registration Dates

• First Submitted: September 29, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Fibrosis; Hypertension, Pulmonary
• Other Study ID Numbers: MED-AUTH-3.1/02-05-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No