Pulmonary Hemodynamics During Exercise - Research Network

NCT03954574 | Recruiting DMC

• 1 other identifier: 30-437 ex 17/18
• Study Type: observational
• Target: 1,500
• Locations: 13 countries
• Sites: 31

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.

Conditions

Pulmonary Circulation Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• Number of Participants undergoing lung Transplantation during observation

  Occurrences of lung transplantations

  6 years

Secondary Outcomes (3)

• Number of Participants being hospitalized during observation

  6 years

• Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization

  6 years

• Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation

  6 years

Study Arms (2)

Retrospective patient cohort

Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization

Prospective patient cohort

Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization

Interventions

assessment of pulmonary hemodynamics during exercise by right heart catheterization DIAGNOSTIC_TEST

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; Retrospective patient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• European Respiratory Society: collaborator

Study Sites (32)

University of Arizona, Banner University Medical Center

Phoenix, Arizona, 85724, United States

RECRUITING

University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine

Los Angeles, California, 90095, United States

RECRUITING

Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital, Cardiology Division and Pulmonary Unit

Boston, Massachusetts, 02114, United States

RECRUITING

Harvard Medical School, Brigham and Women's Hospital

Boston, Massachusetts, 02138, United States

RECRUITING

University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine

Rochester, Minnesota, 85259, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

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

Study Officials

• Horst Olschewski, MD

  Medical University of Graz

  STUDY CHAIR

• Philippe Herve, MD

  Centre Chirugical Marie Lannelongue

  STUDY CHAIR

Central Study Contacts

Gabor Kovacs, MD

CONTACT

+43-316-385; gabor.kovacs@klinikum-graz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: May 17, 2019
• Study Start: December 1, 2018
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

BR (1); FR (4); DE (5); NL (1); BE (1); IT (2); PL (1); ES (1); CH (1); AU (1); GB (4); DK (1); US (8)