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Retrospective Data Analysis of Data From the Zurich PH Registry

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ClinicalTrials.gov Identifier: NCT03198910
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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
Pulmonary Hypertension Chronic Thromboembolic Pulmonary Hypertension Pulmonary Artery Hypertension

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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 : June 2, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : December 31, 2018


Group/Cohort
Pulmonary arterial hypertension
Chronic thromboembolic pulmonary hypertension



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
PAH and CTEPH patients diagnosed with a right heart catheter
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198910


Locations
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Switzerland
Respiratory Clinic, University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03198910     History of Changes
Other Study ID Numbers: Req-2016-00786
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases