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出境医 / 临床实验 / Pulmonary Hemodynamics During Exercise - Research Network (PEX-NET)
Pulmonary Hemodynamics During Exercise - Research Network (PEX-NET)
Study Description
Brief Summary:
The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.
| Condition or disease | Intervention/treatment |
|---|---|
| Pulmonary Circulation Diseases | Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization |
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 6 Years |
| Official Title: | Pulmonary Hemodynamics During Exercise - Research Network |
| Actual Study Start Date : | December 1, 2018 |
| Estimated Primary Completion Date : | December 31, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| Retrospective patient cohort |
Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization
all patients undergo right heart catheterization during exercise due to clinical reasons. Results of this and other Routine clinical tests will be included in the registry
|
| Prospective patient cohort |
Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization
all patients undergo right heart catheterization during exercise due to clinical reasons. Results of this and other Routine clinical tests will be included in the registry
|
Outcome Measures
Primary Outcome Measures :
- Number of Participants who die during observation [ Time Frame: 6 years ]The investigators aim to assess the prognostic relevance of pulmonary hemodynamics during exercise as assessed by right heart catheterization by using a multi-centre approach and to identify independent predictors of adverse events. Separate data sets will be analysed for the retrospective and prospective Evaluation.
- Number of Participants undergoing lung Transplantation during observation [ Time Frame: 6 years ]Occurrences of lung transplantations
Secondary Outcome Measures :
- Number of Participants being hospitalizated during observation [ Time Frame: 6 years ]Number of hospitalizations
- Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization [ Time Frame: 6 years ]Diagnosis of pulmonary hypertension
- Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation [ Time Frame: 6 years ]Evaluation of medication initiations
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients (females and males; age: above 18yrs) with intermediate or high echocardiographic probability of PH and/or unexplained dyspnea, and/or associated conditions for PAH as clinical indication for right heart catheterization at rest and exercise
Criteria
Inclusion Criteria:
- Patients (females and males; age: above 18yrs) with intermediate or high echocardiographic probability of PH and/or unexplained dyspnea, and/or associated conditions for PAH as clinical indication for RHC at rest and exercise
- Written informed consent of participating subjects after being fully briefed (for prospective analysis)
Exclusion Criteria:
- Patients with incomplete hemodynamic data at rest or exercise
- Patients without sufficient follow-up data (information on survival / lung transplantation)
- advanced tumour disease or other diseases with a short life expectancy, except pulmonary vascular diseases
- advanced heart failure with pulmonary arterial wedge pressure (PAWP) > 18 mmHg at rest
- uncontrolled systemic arterial hypertension (RR values > 160/100 mmHg at rest)
- FEV1<50% predicted
- TLC<60% predicted
Contacts and Locations
Contacts
| Contact: Gabor Kovacs, MD | +43-316-385 ext 12183 | gabor.kovacs@klinikum-graz.at |
Locations
Show 32 study locations
Sponsors and Collaborators
Medical University of Graz
European Respiratory Society
Investigators
| Study Chair: | Horst Olschewski, MD | Medical University of Graz | |
| Study Chair: | Philippe Herve, MD | Centre Chirugical Marie Lannelongue |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | March 14, 2019 | ||||||
| First Posted Date | May 17, 2019 | ||||||
| Last Update Posted Date | September 16, 2020 | ||||||
| Actual Study Start Date | December 1, 2018 | ||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Pulmonary Hemodynamics During Exercise - Research Network | ||||||
| Official Title | Pulmonary Hemodynamics During Exercise - Research Network | ||||||
| Brief Summary | The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational [Patient Registry] | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 6 Years | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | Patients (females and males; age: above 18yrs) with intermediate or high echocardiographic probability of PH and/or unexplained dyspnea, and/or associated conditions for PAH as clinical indication for right heart catheterization at rest and exercise | ||||||
| Condition | Pulmonary Circulation Diseases | ||||||
| Intervention | Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization
all patients undergo right heart catheterization during exercise due to clinical reasons. Results of this and other Routine clinical tests will be included in the registry
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
1500 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | December 31, 2023 | ||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | Australia, Austria, Belgium, Brazil, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03954574 | ||||||
| Other Study ID Numbers | 30-437 ex 17/18 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Medical University of Graz | ||||||
| Study Sponsor | Medical University of Graz | ||||||
| Collaborators | European Respiratory Society | ||||||
| Investigators |
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| PRS Account | Medical University of Graz | ||||||
| Verification Date | September 2020 | ||||||
