Exercise Pulmonary HypertensionNCT03706820
Exercise Hemodynamics in Patients With Pulmonary Fibrosis
An observational study of Exercise Pulmonary Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Exercise Pulmonary Hypertension
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 7 May 2018to 15 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- Forced vital capacity (FVC) ≥ 40 %
Who cannot join
- 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.
- History of pulmonary embolism during the year before enrollment
- Presence of severe valvular disease.
- Current treatment with vasoactive drugs of the pulmonary circulation
- Pulmonary wedge pressure (PAWP) at rest > 15 mmHg
Trial locations and contacts
1 site in 1 country.
Georgia G Pitsiou, MD, PhD contact
Greece1 site, 1 recruiting
- Recruiting
G.H. G. Papanikolaou
Thessaloniki, Asvestochori, 57010
Evangelia S Panagiotidou, MD, +306949139509, evangeliapanagiotidou@gmail.com
About this study
Official title: 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.
Read the 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:
- to evaluate the response of the hemodynamic parameters at exercise compared to the resting parameters in this patient group.
- to discriminate between precapillary from postcapillary etiology of pulmonary hypertension.
- to correlate non-invasive parameters of functional limitation with invasive hemodynamic parameters.
- to assess the prognostic role of exercise induced pulmonary hypertension in the specific patient group.
- Conditions
- Exercise Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal rest and exercise hemodynamics | Not described | |
| normal rest and abnormal exercise hemodynamics | Not described | |
| resting pulmonary hypertension | Not described | |
| abnormal wedge pressure at exercise | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2nd minute,4th minute, 6th minute, 8th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start7 May 2018
- Primary completion1 Jun 2018
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Exercise Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EVAGGELIA PANAGIOTIDOU, Aristotle University Of Thessaloniki
- Investigators
- Georgia G Pitsiou, MD, PhD, Study chair, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706820
- Sponsor's protocol ID
- MED-AUTH-3.1/02-05-2018
- Status last verified
- Oct 2018
- First submitted
- 29 Sep 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29167297Herve 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.
PubMed 26022955Panagiotidou 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. 2024 Mar-Apr;30(2):104-112. doi: 10.1016/j.pulmoe.2022.03.012. Epub 2022 May 11.
PubMed 35568651
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Study of the Pulmonary Circulation in Exercise in Patients With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03706820
- Acronym / sponsor ID
- MED-AUTH-3.1/02-05-2018
- Conditions
- Exercise Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to evaluate the response of the hemodynamic parameters at exercise compared to the resting parameters in this patient group.
- to discriminate between precapillary from postcapillary etiology of pulmonary hypertension.
- to correlate non-invasive parameters of functional limitation with invasive hemodynamic parameters.
- to assess the prognostic role of exercise induced pulmonary hypertension in the specific patient group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal rest and exercise hemodynamics | – | – |
| normal rest and abnormal exercise hemodynamics | – | – |
| resting pulmonary hypertension | – | – |
| abnormal wedge pressure at exercise | – | – |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
- Forced vital capacity (FVC) ≥ 40 %
Key exclusion criteria (5 listed)
- 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.
- History of pulmonary embolism during the year before enrollment
- Presence of severe valvular disease.
- Current treatment with vasoactive drugs of the pulmonary circulation
- Pulmonary wedge pressure (PAWP) at rest > 15 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Results publication: PubMed 29167297Kovacs 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.
- Results publication: PubMed 26022955Herve 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.
- Derived from this study: PubMed 35568651Panagiotidou 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. 2024 Mar-Apr;30(2):104-112. doi: 10.1016/j.pulmoe.2022.03.012. Epub 2022 May 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgia G Pitsiou, MD, PhD contact
Georgia G Pitsiou, MD, PhD study chair
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Pulmonary Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evangelia S Panagiotidou, MD (+306949139509, evangeliapanagiotidou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total pulmonary resistance (TPR) from rest to exercise (time frame: 2nd minute,4th minute, 6th minute, 8th minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03706820, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.