Pulmonary HypertensionNCT02777957
Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases
An observational study of Pulmonary Hypertension, run by Silesian Centre for Heart Diseases at 1 site in Poland.
Trial summary
First, the aim of the study was to evaluate the usefulness of echocardiographic parameters for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for lung transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2008to Apr 2023
- How long will I take part?
- 3 Years
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with advanced lung diseases referred for lung transplantation. All patients underwent examinations as potential candidates for lung transplantation, including laboratory testing, pulmonary function tests, exercise capacity, echocardiography examination, and right heart catheterization. Evaluation for lung transplantation was performed during clinically stable periods in all patients on optimal medical and oxygen therapy.
Who may be able to join
- advanced lung disease
- qualification for lung transplantation
- written informed consent
- pulmonary capillary wedge pressure < 15 mmHg
Who cannot join
- cancer,
- history of idiopathic pulmonary hypertension,
- primary valvular heart diseases,
- coronary artery disease,
- collagen vascular disease,
- history or evidence of left ventricular dysfunction,
Show all 11Show fewer
- atrial fibrillation,
- increased liver enzyme levels ( 3 times the upper laboratory limit),
- renal dysfunction (estimated glomerular filtration rate < 60 ml/min/1.73m2)
- patients who didn't write the personal informed consent
- any specific therapy for PH.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Silesian Centre for Heart Diseases
Zabrze, Silesian Voivodeship, 41-800
About this study
Official title: Predictors and Survival in Pulmonary Hypertension Associated With Severe Lung Disease
First, the aim of the study was to evaluate the usefulness of echocardiographic parameters for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for lung transplantation. Second, to assess the prevalence of PH and to identify which hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with severe lung diseases referred for lung transplantation.
- Conditions
- Pulmonary Hypertension
- Keywords
- Echocardiography, Lung Transplantation
- Medical subject headings
- Hypertension, Pulmonary
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 |
|---|---|---|
| mPAP ≥ 25 mmHg | mean pulmonary artery pressure (mPAP) ≥ 25 mmHg (37 patients) | |
| mPAP < 25 mmHg | mean pulmonary artery pressure (mPAP) < 25 mmHg (28 patients). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival after the initial right heart catheterization (RHC) measurements
Measured: 1 year
Secondary outcomes (1)
Survival to lung transplantation or the end of the observation period after the initial right heart catheterization (RHC) measurement
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startDec 2008
- Primary completionApr 2020
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Silesian Centre for Heart Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanta Nowak, Silesian Centre for Heart Diseases
- Investigators
- Jolanta Nowak, MD, PhD, Principal investigator, 3rd Department of Cardiology, Silesian Centre for Heart DiseasesMariusz Gasior, Prof., PhD, Study chair, 3rd Department of Cardiology, Silesian Centre for Heart DiseasesSlawomir Zeglen, MD, PhD, Study chair, Departament of Cardiac Surgery and Transplantology, Silesian Centre for Heart DiseasesJacek Wojarski, MD, PhD, Study chair, Departament of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777957
- Sponsor's protocol ID
- SilesianCHD
- Status last verified
- May 2020
- First submitted
- 18 May 2016
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nowak J, Hudzik B, Jastrzebski D, Niedziela JT, Rozentryt P, Wojarski J, Ochman M, Karolak W, Zeglen S, Gierlotka M, Gasior M. Pulmonary hypertension in advanced lung diseases: Echocardiography as an important part of patient evaluation for lung transplantation. Clin Respir J. 2018 Mar;12(3):930-938. doi: 10.1111/crj.12608. Epub 2017 Jan 12.
PubMed 28052583
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Survival in Pulmonary Hypertension Associated With Severe Lung Disease
- ClinicalTrials.gov ID
- NCT02777957
- Acronym / sponsor ID
- SilesianCHD
- Conditions
- Pulmonary Hypertension
- Keywords
- Echocardiography, Lung Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Silesian Centre for Heart DiseasesUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2023 (estimated)
- First posted
- 19 May 2016 (estimated)
- 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.
First, the aim of the study was to evaluate the usefulness of echocardiographic parameters for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for lung transplantation. Second, to assess the prevalence of PH and to identify which hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with severe lung diseases referred for lung transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mPAP ≥ 25 mmHg | – | –mean pulmonary artery pressure (mPAP) ≥ 25 mmHg (37 patients) |
| mPAP < 25 mmHg | – | –mean pulmonary artery pressure (mPAP) < 25 mmHg (28 patients). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with advanced lung diseases referred for lung transplantation. All patients underwent examinations as potential candidates for lung transplantation, including laboratory testing, pulmonary function tests, exercise capacity, echocardiography examination, and right heart catheterization. Evaluation for lung transplantation was performed during clinically stable periods in all patients on optimal medical and oxygen therapy.
Key inclusion criteria (4 listed)
- advanced lung disease
- qualification for lung transplantation
- written informed consent
- pulmonary capillary wedge pressure < 15 mmHg
Key exclusion criteria (11 listed)
- cancer,
- history of idiopathic pulmonary hypertension,
- primary valvular heart diseases,
- coronary artery disease,
- collagen vascular disease,
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
Survival after the initial right heart catheterization (RHC) measurements
Time frame: 1 year
1 secondary outcome
Survival to lung transplantation or the end of the observation period after the initial right heart catheterization (RHC) measurement
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 28052583Nowak J, Hudzik B, Jastrzebski D, Niedziela JT, Rozentryt P, Wojarski J, Ochman M, Karolak W, Zeglen S, Gierlotka M, Gasior M. Pulmonary hypertension in advanced lung diseases: Echocardiography as an important part of patient evaluation for lung transplantation. Clin Respir J. 2018 Mar;12(3):930-938. doi: 10.1111/crj.12608. Epub 2017 Jan 12.
- Individual participant dataSharing planned: No
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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.
Jolanta Nowak, MD, PhD principal investigator
3rd Department of Cardiology, Silesian Centre for Heart Diseases
Mariusz Gasior, Prof., PhD study chair
3rd Department of Cardiology, Silesian Centre for Heart Diseases
Slawomir Zeglen, MD, PhD study chair
Departament of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases
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 Pulmonary Hypertension, run by Silesian Centre for Heart Diseases at 1 site in Poland.
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 4 inclusion and 11 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 27 May 2020. 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 Poland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival after the initial right heart catheterization (RHC) measurements (time frame: 1 year). 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 NCT02777957, which also lists 1 linked publication.
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 27 May 2020.