NCT03198910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

June 20, 2017

Last Update Submit

August 12, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

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

    Baseline, 3 months, 6 months, 1 year

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

    Baseline, 3 months, 6 months, 1 year

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

    Baseline, 3 months, 6 months, 1 year

Study Arms (2)

Pulmonary arterial hypertension

Chronic thromboembolic pulmonary hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

PAH and CTEPH patients diagnosed with a right heart catheter

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension, PulmonaryFamilial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 26, 2017

Study Start

June 2, 2017

Primary Completion

September 1, 2017

Study Completion

December 31, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations