Recruiting NCT03954574
Pulmonary Hemodynamics During Exercise - Research Network
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: assessment of pulmonary hemodynamics during exercise by right heart catheterization.
- Who it may be relevant to
- Registry conditions: Pulmonary Circulation Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Belgium, Brazil +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test 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
Primary outcome measures
- Number of Participants who die during observation [Time frame: 6 years]
- Number of Participants undergoing lung Transplantation during observation [Time frame: 6 years]
Secondary outcome measures (3)
- Number of Participants being hospitalized during observation [Time frame: 6 years]
- Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization [Time frame: 6 years]
- Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation [Time frame: 6 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 8 centers
- University of Arizona, Banner University Medical Center — Phoenix
- University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hyperten — Los Angeles
- Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA — Baltimore
- Massachusetts General Hospital, Cardiology Division and Pulmonary Unit — Boston
- Harvard Medical School, Brigham and Women's Hospital — Boston
- University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Li — Minneapolis
- Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine — Rochester
- Medical University of South Carolina — Charleston
Germany · 5 centers
- University of Cologne, Klinik III fuer Innere Medizin — Cologne
- Justus-Liebig-University Giessen, Department of Internal Medicine — Giessen
- University of Greifswald — Greifswald
- Thorax Clinic Heidelberg, Centre for Pulmonary Hypertension — Heidelberg
- Academic Teaching Hospital of the Julius Maximilian University of Würzburg — Würzburg
France · 4 centers
- Université de Lorraine — Nancy
- Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery — Paris
- Centre de Référence de l'Hypertension Pulmonaire, Université ParisSud - Université Paris-S — Paris
- Sorbonne Universités, Neurophysiologie respiratoire expérimentale et clinique — Paris
United Kingdom · 4 centers
- Scottish Pulmonary Vascular Unit — Glasgow
- Imperial College, NHS Healthcare NHS Trust, National Pulmonary Hypertension Service — London
- Royal Brompton Hospital — London
- Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit — Sheffield
Italy · 2 centers
- University of Bologna — Bologna
- University of Rome La Sapienza, Cardiovascular and Respiratory Sciences — Roma
Australia · 1 center
- Royal Prince Alfred Hospital, Respiratory Medicine — Camperdown
Austria · 1 center
- Medical University of Graz — Graz
Belgium · 1 center
- Free University of Brussels, Faculty of Medicine, Physiology — Brussels
Brazil · 1 center
- University of São Paulo Medical School — São Paulo
Denmark · 1 center
- Department of Cardiology, Aarhus University Hospital, Denmark — Aarhus
Netherlands · 1 center
- VU Medisch Centrum, Pulmonology — Amsterdam
Poland · 1 center
- Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and T — Otwock
Spain · 1 center
- Barcelona Hospital Clínic, Pneumologia — Barcelona
Switzerland · 1 center
- University Hospital of Zurich, Internal Medicine — Zurich
Identifiers
NCT: NCT03954574 · 30-437 ex 17/18