Pulmonary Hemodynamics During Exercise - Research Network

Обзор

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Number of Participants who die during observation [Срок оценки: 6 years]
• Number of Participants undergoing lung Transplantation during observation [Срок оценки: 6 years]

Вторичные конечные точки (3)

• Number of Participants being hospitalized during observation [Срок оценки: 6 years]
• Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization [Срок оценки: 6 years]
• Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation [Срок оценки: 6 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 8 центров

• 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

Германия · 5 центров

• 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

Франция · 4 центра

• 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

Великобритания · 4 центра

• 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

Италия · 2 центра

• University of Bologna — Bologna
• University of Rome La Sapienza, Cardiovascular and Respiratory Sciences — Roma

Австралия · 1 центр

• Royal Prince Alfred Hospital, Respiratory Medicine — Camperdown

Австрия · 1 центр

• Medical University of Graz — Graz

Бельгия · 1 центр

• Free University of Brussels, Faculty of Medicine, Physiology — Brussels

Бразилия · 1 центр

• University of São Paulo Medical School — São Paulo

Дания · 1 центр

• Department of Cardiology, Aarhus University Hospital, Denmark — Aarhus

Нидерланды · 1 центр

• VU Medisch Centrum, Pulmonology — Amsterdam

Польша · 1 центр

• Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and T — Otwock

Испания · 1 центр

• Barcelona Hospital Clínic, Pneumologia — Barcelona

Швейцария · 1 центр

• University Hospital of Zurich, Internal Medicine — Zurich

Идентификаторы

NCT: NCT03954574 · 30-437 ex 17/18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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