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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03198910
Other study ID # Req-2016-00786
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2017
Est. completion date December 31, 2018

Study information

Verified date August 2019
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 313
Est. completion date December 31, 2018
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

-

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Respiratory Clinic, University Hospital of Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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