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Retrospective Data Analysis of Data From the Zurich PH Registry

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT03198910
Collaborator
(none)
313
Enrollment
1
Location
19
Actual Duration (Months)
16.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    313 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Efficacy of Medical Therapy for Pulmonary Arterial and Inoperable Chronic Thromboembolic Pulmonary Hypertension in a Real Life Setting
    Actual Study Start Date :
    Jun 2, 2017
    Actual Primary Completion Date :
    Sep 1, 2017
    Actual Study Completion Date :
    Dec 31, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Pulmonary arterial hypertension
    Chronic thromboembolic pulmonary hypertension

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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 Outcome Measures

    1. 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

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Respiratory Clinic, University Hospital of Zurich Zurich Switzerland 8091

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT03198910
    Other Study ID Numbers:
    • Req-2016-00786
    First Posted:
    Jun 26, 2017
    Last Update Posted:
    Aug 13, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Pulmonary Arterial Hypertension
    Hypertension

    Study Results

    No Results Posted as of Aug 13, 2019