Retrospective Data Analysis of Data From the Zurich PH Registry

Study Overview
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Brief Summary
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The collected data from the Zurich Registry for pulmonary Hypertension (PH) are evaluated in a retrospective analysis. This study examines the number of patients and their exact diagnoses who are treated at the University Hospital of Zurich and potentially other participating in the Zurich Registry. Other demographic parameters such as age, gender and body-mass-index are also part of the evaluation. Furthermore, the analysis will focus on the newest guidelines on PH. Therefore, it will be checked how many patients would fulfill the therapeutic goals in terms of New York Heart Classification (NYHA), 6-minute walk distance, sign of right heart failure and N-terminal pro-brain-natriuretic peptide(NTproBNP). Additionally, the study examines on how the patients are treated. Despite the different kind of Drugs, the focus lies on the combination therapy (single, double, triple) and the impact the therapy had on the patients.

Official Title
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Efficacy of Medical Therapy for Pulmonary Arterial and Inoperable Chronic Thromboembolic Pulmonary Hypertension in a Real Life Setting

Conditions
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Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Artery Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pulmonary arterial hypertension (PAH) Patients with chronic thromboembolic pulmonary hypertension (CTEPH) All prevalent patients (diagnosed >12 month ago) with PAH or distal CTEPH who had a consultation at the PH centre in Zurich between November 2015 and November 2016) Exclusion Criteria: -

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 |
| --- | --- |
| Pulmonary arterial hypertension<br> | |
| Chronic thromboembolic pulmonary hypertension<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NYHA/WHO functional class | Change of the functional class over time in relation to given vasodilator treatment | Baseline, 3 months, 6 months, 1 year | 
| Change in 6 minute walk distance | Change of the 6 minute walk distance over time in relation to given vasodilator treatment | Baseline, 3 months, 6 months, 1 year | 
| Change in NT-proBNP | Change of the 6 minute walk distance over time in relation to given vasodilator treatment | Baseline, 3 months, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients that are in NYHA/WHO functional class <= II | Percentage of patients that are in NYHA/WHO functional class <= II will be assessed at respective timepoints | Baseline, 3 months, 6 months, 1 year | 
| Percentage of patients with a 6 minute walk distance > 440m | Percentage of patients with a 6 minute walk distance > 440m will be assessed at respective timepoints | Baseline, 3 months, 6 months, 1 year | 
| Percentage of patients with a NT-proBNP < 300 ng/l | Percentage of patients with a NT-proBNP < 300 ng/l will be assessed at respective timepoints | Baseline, 3 months, 6 months, 1 year |