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Pulmonary Hemodynamics During Exercise - Research Network (PEX-NET)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03954574
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : October 18, 2021
Sponsor:
Collaborator:
European Respiratory Society
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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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
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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

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Groups and Cohorts
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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
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Primary Outcome Measures :
  1. 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.

  2. Number of Participants undergoing lung Transplantation during observation [ Time Frame: 6 years ]
    Occurrences of lung transplantations


Secondary Outcome Measures :
  1. Number of Participants being hospitalized during observation [ Time Frame: 6 years ]
    Number of hospitalizations

  2. Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization [ Time Frame: 6 years ]
    Diagnosis of pulmonary hypertension

  3. Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation [ Time Frame: 6 years ]
    Evaluation of medication initiations


Eligibility Criteria
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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
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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): NCT03954574


Contacts
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Contact: Gabor Kovacs, MD +43-316-385 ext 12183 gabor.kovacs@klinikum-graz.at

Locations
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Sponsors and Collaborators
Medical University of Graz
European Respiratory Society
Investigators
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Study Chair: Horst Olschewski, MD Medical University of Graz
Study Chair: Philippe Herve, MD Centre Chirugical Marie Lannelongue
More Information
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03954574    
Other Study ID Numbers: 30-437 ex 17/18
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
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