Retrospective Data Analysis of Data From the Zurich PH Registry

Completed

• Conditions: Pulmonary Hypertension; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension

• Registration Number: NCT03198910
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-02
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Primary Completion: 2017-09-01
• Study Completion: 2018-12-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Respiratory Clinic, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland