Pulmonary Hemodynamics During Exercise - Research Network
- Conditions
- Pulmonary Circulation Diseases
- Interventions
- Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization
- Registration Number
- NCT03954574
- Lead Sponsor
- Medical University of Graz
- 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 available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective patient cohort assessment of pulmonary hemodynamics during exercise by right heart catheterization - Retrospective patient cohort assessment of pulmonary hemodynamics during exercise by right heart catheterization -
- Primary Outcome Measures
Name Time Method Number of Participants who die during observation 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 6 years Occurrences of lung transplantations
- Secondary Outcome Measures
Name Time Method Number of Participants being hospitalized during observation 6 years Number of hospitalizations
Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization 6 years Diagnosis of pulmonary hypertension
Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation 6 years Evaluation of medication initiations
Trial Locations
- Locations (32)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Sorbonne Universités, Neurophysiologie respiratoire expérimentale et clinique
🇫🇷Paris, France
Justus-Liebig-University Giessen, Department of Internal Medicine
🇩🇪Gießen, Germany
Imperial College, NHS Healthcare NHS Trust, National Pulmonary Hypertension Service
🇬🇧London, United Kingdom
University of Rome La Sapienza, Cardiovascular and Respiratory Sciences
🇮🇹Roma, Italy
Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery
🇫🇷Paris, France
University of São Paulo Medical School
🇧🇷São Paulo, Brazil
Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine
🇺🇸Rochester, Minnesota, United States
Centre de Référence de l'Hypertension Pulmonaire, Université ParisSud - Université Paris-Saclay, Hôpital Bicêtre, Assistance Publique Hôpitaux de Paris
🇫🇷Paris, France
Medical University of Graz
🇦🇹Graz, Austria
Scottish Pulmonary Vascular Unit
🇬🇧Glasgow, United Kingdom
Free University of Brussels, Faculty of Medicine, Physiology
🇧🇪Brussels, Belgium
University of Bologna
🇮🇹Bologna, Italy
Thorax Clinic Heidelberg, Centre for Pulmonary Hypertension
🇩🇪Heidelberg, Germany
Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit
🇬🇧Sheffield, United Kingdom
Barcelona Hospital ClÃnic, Pneumologia
🇪🇸Barcelona, Spain
Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA
🇺🇸Baltimore, Maryland, United States
Université de Lorraine
🇫🇷Nancy, France
University of Cologne, Klinik III fuer Innere Medizin
🇩🇪Cologne, Germany
Royal Prince Alfred Hospital, Respiratory Medicine
🇦🇺Camperdown, Australia
Academic Teaching Hospital of the Julius Maximilian University of Würzburg
🇩🇪Würzburg, Germany
University of Greifswald
🇩🇪Greifswald, Germany
University of Arizona, Banner University Medical Center
🇺🇸Phoenix, Arizona, 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
Massachusetts General Hospital, Cardiology Division and Pulmonary Unit
🇺🇸Boston, Massachusetts, United States
Harvard Medical School, Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and Thromboembolic Diseases
🇵🇱Otwock, Poland
Department of Cardiology, Aarhus University Hospital, Denmark
🇩🇰Aarhus, Denmark
University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA
🇺🇸Minneapolis, Minnesota, United States
VU Medisch Centrum, Pulmonology
🇳🇱Amsterdam, Netherlands
University Hospital of Zurich, Internal Medicine
🇨ðŸ‡Zürich, Switzerland
Royal Brompton Hospital
🇬🇧London, United Kingdom