Pulmonary Circulation Diseases Clinical Trial
— PEX-NETOfficial title:
Pulmonary Hemodynamics During Exercise - Research Network
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.
| Status | Recruiting |
| Enrollment | 1500 |
| Est. completion date | December 31, 2029 |
| Est. primary completion date | December 31, 2029 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Prince Alfred Hospital, Respiratory Medicine | Camperdown | |
| Austria | Medical University of Graz | Graz | |
| Belgium | Free University of Brussels, Faculty of Medicine, Physiology | Brussels | |
| Brazil | University of São Paulo Medical School | São Paulo | |
| Denmark | Department of Cardiology, Aarhus University Hospital, Denmark | Aarhus | |
| France | Université de Lorraine | Nancy | |
| France | Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery | Paris | |
| France | Centre de Référence de l'Hypertension Pulmonaire, Université ParisSud - Université Paris-Saclay, Hôpital Bicêtre, Assistance Publique Hôpitaux de Paris | Paris | |
| France | Sorbonne Universités, Neurophysiologie respiratoire expérimentale et clinique | Paris | |
| Germany | University of Cologne, Klinik III fuer Innere Medizin | Cologne | |
| Germany | Justus-Liebig-University Giessen, Department of Internal Medicine | Gießen | |
| Germany | University of Greifswald | Greifswald | |
| Germany | Thorax Clinic Heidelberg, Centre for Pulmonary Hypertension | Heidelberg | |
| Germany | Academic Teaching Hospital of the Julius Maximilian University of Würzburg | Würzburg | |
| Italy | University of Bologna | Bologna | |
| Italy | University of Rome La Sapienza, Cardiovascular and Respiratory Sciences | Roma | |
| Netherlands | VU Medisch Centrum, Pulmonology | Amsterdam | |
| Poland | Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and Thromboembolic Diseases | Otwock | |
| Spain | Barcelona Hospital Clínic, Pneumologia | Barcelona | |
| Switzerland | University Hospital of Zurich, Internal Medicine | Zürich | |
| United Kingdom | Scottish Pulmonary Vascular Unit | Glasgow | |
| United Kingdom | Imperial College, NHS Healthcare NHS Trust, National Pulmonary Hypertension Service | London | |
| United Kingdom | Royal Brompton Hospital | London | |
| United Kingdom | Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit | Sheffield | |
| United States | Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA | Baltimore | Maryland |
| United States | Harvard Medical School, Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital, Cardiology Division and Pulmonary Unit | Boston | Massachusetts |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine | Los Angeles | California |
| United States | University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA | Minneapolis | Minnesota |
| United States | University of Arizona, Banner University Medical Center | Phoenix | Arizona |
| United States | Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Graz | European Respiratory Society |
United States, Australia, Austria, Belgium, Brazil, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants who die during observation | 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 | |
| Primary | Number of Participants undergoing lung Transplantation during observation | Occurrences of lung transplantations | 6 years | |
| Secondary | Number of Participants being hospitalized during observation | Number of hospitalizations | 6 years | |
| Secondary | Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization | Diagnosis of pulmonary hypertension | 6 years | |
| Secondary | Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation | Evaluation of medication initiations | 6 years |