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Completed

NCT Number: NCT03198910

Retrospective Data Analysis of Data From the Zurich PH Registry

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Chronic Thromboembolic Pulmonary Hypertension Familial Primary Pulmonary Hypertension Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Artery Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Change in NYHA/WHO functional class

    Time frame: Baseline, 3 months, 6 months, 1 year

    Change of the functional class over time in relation to given vasodilator treatment

  2. Change in 6 minute walk distance

    Time frame: Baseline, 3 months, 6 months, 1 year

    Change of the 6 minute walk distance over time in relation to given vasodilator treatment

  3. Change in NT-proBNP

    Time frame: Baseline, 3 months, 6 months, 1 year

    Change of the 6 minute walk distance over time in relation to given vasodilator treatment

Secondary outcomes

  1. Percentage of patients that are in NYHA/WHO functional class <= II

    Time frame: Baseline, 3 months, 6 months, 1 year

    Percentage of patients that are in NYHA/WHO functional class <= II will be assessed at respective timepoints

  2. Percentage of patients with a 6 minute walk distance > 440m

    Time frame: Baseline, 3 months, 6 months, 1 year

    Percentage of patients with a 6 minute walk distance > 440m will be assessed at respective timepoints

  3. Percentage of patients with a NT-proBNP < 300 ng/l

    Time frame: Baseline, 3 months, 6 months, 1 year

    Percentage of patients with a NT-proBNP < 300 ng/l will be assessed at respective timepoints

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jun 26, 2017
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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