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

January 2, 2024 updated by: Medical University of Graz
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Camperdown, Australia
        • Recruiting
        • Royal Prince Alfred Hospital, Respiratory Medicine
        • Contact:
  • Austria
      • Graz, Austria
  • Belgium
      • Brussels, Belgium
        • Recruiting
        • Free University of Brussels, Faculty of Medicine, Physiology
        • Contact:
  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • University of Sao Paulo Medical School
        • Contact:
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Department of Cardiology, Aarhus University Hospital, Denmark
        • Contact:
  • France
      • Nancy, France
      • Paris, France
        • Recruiting
        • Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery
        • Contact:
      • Paris, France
        • Recruiting
        • Centre de Référence de l'Hypertension Pulmonaire, Université ParisSud - Université Paris-Saclay, Hôpital Bicêtre, Assistance Publique Hôpitaux de Paris
        • Contact:
      • Paris, France
  • Germany
      • Cologne, Germany
      • Gießen, Germany
      • Greifswald, Germany
      • Heidelberg, Germany
      • Würzburg, Germany
  • Italy
      • Bologna, Italy
      • Roma, Italy
        • Recruiting
        • University of Rome La Sapienza, Cardiovascular and Respiratory Sciences
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • VU Medisch Centrum, Pulmonology
        • Contact:
  • Poland
      • Otwock, Poland
        • Recruiting
        • Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and Thromboembolic Diseases
        • Contact:
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Barcelona Hospital Clínic, Pneumologia
        • Contact:
  • Switzerland
      • Zürich, Switzerland
        • Recruiting
        • University Hospital of Zurich, Internal Medicine
        • Contact:
  • United Kingdom
      • Glasgow, United Kingdom
        • Recruiting
        • Scottish Pulmonary Vascular Unit
        • Contact:
      • London, United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College, NHS Healthcare NHS Trust, National Pulmonary Hypertension Service
        • Contact:
      • Sheffield, United Kingdom
        • Recruiting
        • Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85724
        • Recruiting
        • University of Arizona, Banner University Medical Center
        • Contact:
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02138
        • Recruiting
        • Harvard Medical School, Brigham and Women's Hospital
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA
        • Contact:
      • Rochester, Minnesota, United States, 85259
        • Recruiting
        • Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 years
Number of Participants undergoing lung Transplantation during observation
Time Frame: 6 years
Occurrences of lung transplantations
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants being hospitalized during observation
Time Frame: 6 years
Number of hospitalizations
6 years
Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization
Time Frame: 6 years
Diagnosis of pulmonary hypertension
6 years
Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation
Time Frame: 6 years
Evaluation of medication initiations
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

European Respiratory Society

Investigators

  • Study Chair: Horst Olschewski, MD, Medical University of Graz
  • Study Chair: Philippe Herve, MD, Centre Chirugical Marie Lannelongue

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (Actual)

May 17, 2019

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 30-437 ex 17/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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