Clinical trial NCT03954574: Pulmonary Hemodynamics During Exercise - Research Network
Official title: Pulmonary Hemodynamics During Exercise - Research Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Circulation Diseases
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: European Respiratory Society
First posted: 2019-05-17
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants who die during observation
timeFrame: 6 years
measure: Number of Participants undergoing lung Transplantation during observation
timeFrame: 6 years
Secondary outcomes:
measure: Number of Participants being hospitalized during observation
timeFrame: 6 years
measure: Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization
timeFrame: 6 years
measure: Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation
timeFrame: 6 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona, Banner University Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital, Cardiology Division and Pulmonary Unit
state: Massachusetts
city: Boston
country: United States
facility: Harvard Medical School, Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine
state: Minnesota
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital, Respiratory Medicine
city: Graz
country: Austria
facility: Medical University of Graz
city: Brussels
country: Belgium
facility: Free University of Brussels, Faculty of Medicine, Physiology
city: São Paulo
country: Brazil
facility: University of São Paulo Medical School
city: Aarhus
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital, Denmark
city: Nancy
country: France
facility: Université de Lorraine
city: Paris
country: France
facility: Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery
city: Paris
country: France
facility: Centre de Référence de l'Hypertension Pulmonaire, Université ParisSud - Université Paris-Saclay, Hôpital Bicêtre, Assistance Publique Hôpitaux de Paris
city: Paris
country: France
facility: Sorbonne Universités, Neurophysiologie respiratoire expérimentale et clinique
city: Cologne
country: Germany
facility: University of Cologne, Klinik III fuer Innere Medizin
city: Gießen
country: Germany
facility: Justus-Liebig-University Giessen, Department of Internal Medicine
city: Greifswald
country: Germany
facility: University of Greifswald
city: Heidelberg
country: Germany
facility: Thorax Clinic Heidelberg, Centre for Pulmonary Hypertension
city: Würzburg
country: Germany
facility: Academic Teaching Hospital of the Julius Maximilian University of Würzburg
city: Bologna
country: Italy
facility: University of Bologna
city: Roma
country: Italy
facility: University of Rome La Sapienza, Cardiovascular and Respiratory Sciences
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum, Pulmonology
city: Otwock
country: Poland
facility: Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and Thromboembolic Diseases
city: Barcelona
country: Spain
facility: Barcelona Hospital Clínic, Pneumologia
city: Zürich
country: Switzerland
facility: University Hospital of Zurich, Internal Medicine
city: Glasgow
country: United Kingdom
facility: Scottish Pulmonary Vascular Unit
city: London
country: United Kingdom
facility: Imperial College, NHS Healthcare NHS Trust, National Pulmonary Hypertension Service
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit
Study officials:
affiliation: Medical University of Graz
name: Horst Olschewski, MD
role: STUDY_CHAIR
affiliation: Centre Chirugical Marie Lannelongue
name: Philippe Herve, MD
role: STUDY_CHAIR
References: