Retrospective Data Analysis of Data From the Zurich PH Registry
Efficacy of Medical Therapy for Pulmonary Arterial and Inoperable Chronic Thromboembolic Pulmonary Hypertension in a Real Life Setting
1 other identifier
observational
313
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2017
CompletedFirst Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedAugust 13, 2019
August 1, 2019
3 months
June 20, 2017
August 12, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Percentage of patients that are in NYHA/WHO functional class <= II
Baseline, 3 months, 6 months, 1 year
Percentage of patients with a 6 minute walk distance > 440m
Baseline, 3 months, 6 months, 1 year
Percentage of patients with a NT-proBNP < 300 ng/l
Baseline, 3 months, 6 months, 1 year
Study Arms (2)
Pulmonary arterial hypertension
Chronic thromboembolic pulmonary hypertension
Eligibility Criteria
PAH and CTEPH patients diagnosed with a right heart catheter
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 26, 2017
Study Start
June 2, 2017
Primary Completion
September 1, 2017
Study Completion
December 31, 2018
Last Updated
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share