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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 313

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Respiratory Clinic, University Hospital of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

PAH and CTEPH patients diagnosed with a right heart catheter

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pulmonary arterial hypertension
Chronic thromboembolic pulmonary hypertension

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: Req-2016-00786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No