Pulmonary Hemodynamics During Exercise - Research Network

NCT03954574 · tracked via the Priya Life Science Germany tracker

Sponsor

Medical University of Graz

Phase

Observational

Started

2018-12-01

Last updated

2025-04-27

Condition(s) studied

Pulmonary Circulation Diseases

Investigational drug(s) / intervention(s)

assessment of pulmonary hemodynamics during exercise by right heart catheterization

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (32)

Facility	City	Region	Status
University of Arizona, Banner University Medical Center	Phoenix	Arizona	Recruiting
University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine	Los Angeles	California	Recruiting
Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA	Baltimore	Maryland	Recruiting
Massachusetts General Hospital, Cardiology Division and Pulmonary Unit	Boston	Massachusetts	Recruiting
Harvard Medical School, Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA	Minneapolis	Minnesota	Recruiting
Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine	Rochester	Minnesota	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
Royal Prince Alfred Hospital, Respiratory Medicine	Camperdown	Australia	Recruiting
Medical University of Graz	Graz	Austria	Recruiting
Free University of Brussels, Faculty of Medicine, Physiology	Brussels	Belgium	Recruiting
University of São Paulo Medical School	São Paulo	Brazil	Recruiting
Department of Cardiology, Aarhus University Hospital, Denmark	Aarhus	Denmark	Recruiting
Université de Lorraine	Nancy	France	Recruiting
Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery	Paris	France	Recruiting
Centre de Référence de l'Hypertension Pulmonaire, Université ParisSud - Université Paris-Saclay, Hôpital Bicêtre, Assistance Publique Hôpitaux de Paris	Paris	France	Recruiting
Sorbonne Universités, Neurophysiologie respiratoire expérimentale et clinique	Paris	France	Recruiting
University of Cologne, Klinik III fuer Innere Medizin	Cologne	Germany	Recruiting
Justus-Liebig-University Giessen, Department of Internal Medicine	Giessen	Germany	Recruiting
University of Greifswald	Greifswald	Germany	Recruiting
Thorax Clinic Heidelberg, Centre for Pulmonary Hypertension	Heidelberg	Germany	Recruiting
Academic Teaching Hospital of the Julius Maximilian University of Würzburg	Würzburg	Germany	Recruiting
University of Bologna	Bologna	Italy	Recruiting
University of Rome La Sapienza, Cardiovascular and Respiratory Sciences	Roma	Italy	Recruiting
VU Medisch Centrum, Pulmonology	Amsterdam	Netherlands	Recruiting
Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and Thromboembolic Diseases	Otwock	Poland	Recruiting
Barcelona Hospital Clínic, Pneumologia	Barcelona	Spain	Recruiting
University Hospital of Zurich, Internal Medicine	Zurich	Switzerland	Recruiting
Scottish Pulmonary Vascular Unit	Glasgow	United Kingdom	Recruiting
Imperial College, NHS Healthcare NHS Trust, National Pulmonary Hypertension Service	London	United Kingdom	Recruiting
Royal Brompton Hospital	London	United Kingdom	Recruiting
Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit	Sheffield	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03954574 on ClinicalTrials.gov ↗ ← All trials in Germany