Pulmonary HypertensionNCT03198910
Retrospective Data Analysis of Data From the Zurich PH Registry
An observational study of Pulmonary Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Artery Hypertension
- How many people
- 313 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jun 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PAH and CTEPH patients diagnosed with a right heart catheter
Who may be able to join
- 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)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091
About this study
Official title: Efficacy of Medical Therapy for Pulmonary Arterial and Inoperable Chronic Thromboembolic Pulmonary Hypertension in a Real Life Setting
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.
- Conditions
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Artery Hypertension
- Medical subject headings
- Hypertension, Pulmonary, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary arterial hypertension | Not described | |
| Chronic thromboembolic pulmonary hypertension | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NYHA/WHO functional class
Change of the functional class over time in relation to given vasodilator treatment
Measured: 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
Measured: 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
Measured: Baseline, 3 months, 6 months, 1 year
Secondary outcomes (3)
Percentage of patients that are in NYHA/WHO functional class <= II
Percentage of patients that are in NYHA/WHO functional class <= II will be assessed at respective timepoints
Measured: Baseline, 3 months, 6 months, 1 year
Percentage of patients with a 6 minute walk distance > 440m
Percentage of patients with a 6 minute walk distance > 440m will be assessed at respective timepoints
Measured: Baseline, 3 months, 6 months, 1 year
Percentage of patients with a NT-proBNP < 300 ng/l
Percentage of patients with a NT-proBNP < 300 ng/l will be assessed at respective timepoints
Measured: Baseline, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start2 Jun 2017
- Primary completion1 Sep 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198910
- Sponsor's protocol ID
- Req-2016-00786
- Status last verified
- Aug 2019
- First submitted
- 20 Jun 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Medical Therapy for Pulmonary Arterial and Inoperable Chronic Thromboembolic Pulmonary Hypertension in a Real Life Setting
- ClinicalTrials.gov ID
- NCT03198910
- Acronym / sponsor ID
- Req-2016-00786
- Conditions
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Artery Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary arterial hypertension | – | – |
| Chronic thromboembolic pulmonary hypertension | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAH and CTEPH patients diagnosed with a right heart catheter
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
3 secondary outcomes
Percentage of patients that are in NYHA/WHO functional class <= II
Time frame: Baseline, 3 months, 6 months, 1 year
Percentage of patients with a 6 minute walk distance > 440m
Time frame: Baseline, 3 months, 6 months, 1 year
Percentage of patients with a NT-proBNP < 300 ng/l
Time frame: Baseline, 3 months, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NYHA/WHO functional class (time frame: Baseline, 3 months, 6 months, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.