Pulmonary Hemodynamics During Exercise - Research Network

NCT ID: NCT03954574

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Pulmonary Circulation Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Retrospective patient cohort

assessment of pulmonary hemodynamics during exercise by right heart catheterization

Intervention Type 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

assessment of pulmonary hemodynamics during exercise by right heart catheterization

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Respiratory Society

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horst Olschewski, MD

Role: STUDY_CHAIR

Medical University of Graz

Philippe Herve, MD

Role: STUDY_CHAIR

Centre Chirugical Marie Lannelongue

Locations

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University of Arizona, Banner University Medical Center

Phoenix, Arizona, United States

Site Status RECRUITING

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

Los Angeles, California, United States

Site Status RECRUITING

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

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital, Cardiology Division and Pulmonary Unit

Boston, Massachusetts, United States

Site Status RECRUITING

Harvard Medical School, Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

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

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine

Rochester, Minnesota, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Royal Prince Alfred Hospital, Respiratory Medicine

Camperdown, , Australia

Site Status RECRUITING

Medical University of Graz

Graz, , Austria

Site Status RECRUITING

Free University of Brussels, Faculty of Medicine, Physiology

Brussels, , Belgium

Site Status RECRUITING

University of São Paulo Medical School

São Paulo, , Brazil

Site Status RECRUITING

Department of Cardiology, Aarhus University Hospital, Denmark

Aarhus, , Denmark

Site Status RECRUITING

Université de Lorraine

Nancy, , France

Site Status RECRUITING

Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery

Paris, , France

Site Status RECRUITING

Centre de Référence de l'Hypertension Pulmonaire, Université ParisSud - Université Paris-Saclay, Hôpital Bicêtre, Assistance Publique Hôpitaux de Paris

Paris, , France

Site Status RECRUITING

Sorbonne Universités, Neurophysiologie respiratoire expérimentale et clinique

Paris, , France

Site Status RECRUITING

University of Cologne, Klinik III fuer Innere Medizin

Cologne, , Germany

Site Status RECRUITING

Justus-Liebig-University Giessen, Department of Internal Medicine

Giessen, , Germany

Site Status RECRUITING

University of Greifswald

Greifswald, , Germany

Site Status RECRUITING

Thorax Clinic Heidelberg, Centre for Pulmonary Hypertension

Heidelberg, , Germany

Site Status RECRUITING

Academic Teaching Hospital of the Julius Maximilian University of Würzburg

Würzburg, , Germany

Site Status RECRUITING

University of Bologna

Bologna, , Italy

Site Status RECRUITING

University of Rome La Sapienza, Cardiovascular and Respiratory Sciences

Roma, , Italy

Site Status RECRUITING

VU Medisch Centrum, Pulmonology

Amsterdam, , Netherlands

Site Status RECRUITING

Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and Thromboembolic Diseases

Otwock, , Poland

Site Status RECRUITING

Barcelona Hospital Clínic, Pneumologia

Barcelona, , Spain

Site Status RECRUITING

University Hospital of Zurich, Internal Medicine

Zurich, , Switzerland

Site Status RECRUITING

Scottish Pulmonary Vascular Unit

Glasgow, , United Kingdom

Site Status RECRUITING

Imperial College, NHS Healthcare NHS Trust, National Pulmonary Hypertension Service

London, , United Kingdom

Site Status RECRUITING

Royal Brompton Hospital

London, , United Kingdom

Site Status RECRUITING

Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit

Sheffield, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Austria Belgium Brazil Denmark France Germany Italy Netherlands Poland Spain Switzerland United Kingdom

Central Contacts

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Gabor Kovacs, MD

Role: CONTACT

+43-316-385 ext. 12183

Facility Contacts

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Rajeev Saggar

Role: primary

Rajan Saggar

Role: primary

Steven Hsu

Role: primary

Gregory Lewis

Role: primary

Bradley A. Maron

Role: backup

David Systrom

Role: primary

Thenappan Thenappan

Role: primary

Barry Borlaug

Role: primary

Ryan Tedford

Role: primary

Edmund Lau

Role: primary

Gabor Kovacs, MD

Role: primary

+43-316-385 ext. 12183

Robert Naeije

Role: primary

Rogerio Souza

Role: primary

Mads Andersen

Role: primary

Ari Chaouat

Role: primary

Philippe Herve

Role: primary

Marc Humbert

Role: primary

Pierantonio Laveneziana

Role: primary

Stephan Rosenkranz

Role: primary

Henning Gall

Role: primary

Ralf Ewert

Role: primary

Ekkehard Grünig

Role: primary

Matthias Held

Role: primary

Nazzareno Galie

Role: primary

Dario Vizza

Role: primary

Anton vonk Noordegraaf

Role: primary

Adam Torbicki

Role: primary

Joan Albert Barbera

Role: primary

Silvia Ulrich

Role: primary

Martin Johnson

Role: primary

Luke Howard

Role: primary

Colm McCabe

Role: primary

Robin Condliffe

Role: primary

Other Identifiers

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30-437 ex 17/18

Identifier Type: -

Identifier Source: org_study_id

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