Pulmonary Hemodynamics During Exercise - Research Network

Study Overview
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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.

Official Title
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Pulmonary Hemodynamics During Exercise - Research Network

Conditions
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Pulmonary Circulation Diseases

Intervention / Treatment
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* Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective patient cohort<br> | Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization<br>* 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<br>|
| Prospective patient cohort<br> | Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants being hospitalized during observation | Number of hospitalizations | 6 years | 
| Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization | Diagnosis of pulmonary hypertension | 6 years | 
| Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation | Evaluation of medication initiations | 6 years |