Retrospective Data Analysis of Data From the Zurich PH Registry

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198910
• Other study ID #: Req-2016-00786
• Status: Completed
• 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
• 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:

-

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Artery Hypertension
• Pulmonary Hypertension

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