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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03198910

Enrollment

313

Registered

2017-06-26

Start date

2017-06-02

Completion date

2018-12-31

Last updated

2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Artery Hypertension, Pulmonary Hypertension

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

Measure	Time frame	Description
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 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 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

Countries

Switzerland

Outcome results