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Exercise Hemodynamics in Patients With Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
EVAGGELIA PANAGIOTIDOU, 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Evangelia S Panagiotidou, MD +306949139509 evangeliapanagiotidou@gmail.com
Contact: Georgia G Pitsiou, MD, PhD gpitsiou@yahoo.gr

Locations
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Greece
G.H. G. Papanikolaou Recruiting
Thessaloniki, Asvestochori, Greece, 57010
Contact: Evangelia S Panagiotidou, MD    +306949139509    evangeliapanagiotidou@gmail.com   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Study Chair: Georgia G Pitsiou, MD, PhD Aristotle University Of Thessaloniki
Publications of Results:
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Responsible Party: EVAGGELIA PANAGIOTIDOU, Phd candidate, Resident of Pulmonary medicine, G.H.G.Papanikolaou, Thessaloniki, Greece, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03706820    
Other Study ID Numbers: MED-AUTH-3.1/02-05-2018
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Fibrosis
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases