Pulmonary Hypertension Outcome AssessmentZHPHCohortNCT02249806
Zürich Pulmonary Hypertension Outcome Assessment Cohort
An observational study of Pulmonary Hypertension Outcome Assessment, run by University of Zurich at 1 site in Switzerland.
Trial summary
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Hypertension Outcome Assessment
- What is being tested?
- PH target therapy according to physician
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to Sep 2024
- How long will I take part?
- 10 Years
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with precapillary pulmonary hypertension classified according to WHO
Who may be able to join
- Patients with precapillary pulmonary hypertension
- Adult male and female patients of all ages referred to our center for evaluation/treatment of PH
- Written informed consent by the subject after information about the research project
Who cannot join
- Patients with severe concomitant left heart disease (left ventricular ejection fraction <40%).
- Patients with restrictive lung disease (FVC<60% predicted); obstructive lung disease (forced expiratory volume (FEV) <60% predicted, with FEV 1/FVC<70%).
- Patients with any other disease limiting their ability to move (skeletal disease, neurological disease, etc.)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zürich
Zurich, 8091
Silvia Ulrich, PD MD, 0041 44 255 22 20, silvia.ulrich@usz.ch
Silvia Ulrich, MD
About this study
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigators intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters.
Read the detailed description
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Advances in medical therapy have improved survival according to recent registries, but are associated with high healthcare costs. Most treatment trials and clinical follow-up assessments rely on the 6 minute walk distance as main outcome parameter although submaximal exercise performance reflects only one disease aspect.
Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigator intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters. New outcomes to be assessed will be home based activity monitoring, novel physiological measures, namely cerebral and muscle tissue oxygenation at rest and during exercise testing, stair ascent on mechanograph, sit to stand test and several serum markers and micro-RNA. All these assessments will be compared with hard endpoints events (death, lung-transplantation, hospitalization for PH), and with traditional outcome measures such as NYHA functional class, 6 minute walk distance, generic quality of life, cardiopulmonary exercise tests, sleep studies, health preference (utility) and cognitive function.
- Being tested
- PH target therapy according to physician
- Keywords
- Pulmonary Hypertension, Chronic thromboembolic pulmonary hypertension, Pulmonary arterial hypertension, Outcome
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH target therapy according to physicianOther
Patients receiving PH target therapy
| Study group | Role | What they receive |
|---|---|---|
| PH target therapy | Patients receiving PH target therapy Receives: Other: PH target therapy according to physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Transplant free survival will be registered
Measured: 10 years
Change in the 6 minute walk distance
The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
Secondary outcomes (17)
New York Heart association (NYHA) functional class
The change in NYHA class will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
Score in health related Quality of Life (HRQoL) questionnaires
The change in HRQoL class will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
Hemodynamic parameters by echocardiography
The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
Hospital days
Days spent in the hospital
Measured: 10 years
red- and white blood cell counts
The change in blood cell count will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes
The change in arterial blood gas parameters taken from radial artery will be registered at 3, 6, 12 months and yearly thereafter, (ABL '90Flex'-blood gas analyzer, Radiometer, Switzerland)
Measured: 10 years
Score on Short-Form-6 D, Euro-Qol 5 D (EQ-5 D), visual analogue scale, time trade-off, standard gamble test
The change in utility will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
Overnight sleep study parameters
The change Overnight sleep study parameters will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
Score in cognitive function tests
The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
Cardiopulmonary exercise test parameters
The change cardiopulmonary exercise test parameters will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
ECG parameters
The change in ECG parameters will be registered at 3, 6, 12 months and yearly thereafter
Measured: 10 years
Motion, step counts, metabolic equivalent
The change in Activity assessment parameters will be registered at 3, 6, 12 months and yearly thereafter with actigraphy
Measured: 10 years
Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue
Changes in cerebral and muscle tissue oxygenation will be assessed after 3, 6, 12 months and yearly thereafter by Near-infrared-Spectroscopy
Measured: 10 years
Time, maximal power in stair-ascent test
Changes in performance of stair ascent test will be assessed after 3, 6, 12 months and yearly thereafter
Measured: 10 years
Performance in Sit to stand test
Changes in sit- to stand test will be assessed after 3, 6, 12 months and yearly thereafter
Measured: 10 years
Level of C-reactive protein (CRP)
The change in CRP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by immunoassay ('Immulite 2000'; 'DPC'; Los Angeles; USA)
Measured: 10 years
Level of N-terminal brain natriuretic peptide (BNP)
The change in BNP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by Roche Modular Systems (Roche; Switzerland)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Hypertension Outcome AssessmentStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, MD, Principal investigator, University Hospital Zurich, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249806
- Sponsor's protocol ID
- 2014-0214_ZH PH Cohort
- Acronym
- ZHPHCohort
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2014
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Saxer S, Lichtblau M, Berlier C, Hasler ED, Schwarz EI, Ulrich S. Physical activity in incident patients with pulmonary arterial and chronic thromboembolic hypertension. Lung. 2019 Oct;197(5):617-625. doi: 10.1007/s00408-019-00248-x. Epub 2019 Jul 1.
PubMed 31263960
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zürich Pulmonary Hypertension Outcome Assessment Cohort
- ClinicalTrials.gov ID
- NCT02249806
- Acronym / sponsor ID
- ZHPHCohort / 2014-0214_ZH PH Cohort
- Keywords
- Pulmonary Hypertension, Chronic thromboembolic pulmonary hypertension, Pulmonary arterial hypertension, Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 26 Sep 2014 (estimated)
- 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.
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigators intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters.
Detailed description
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Advances in medical therapy have improved survival according to recent registries, but are associated with high healthcare costs. Most treatment trials and clinical follow-up assessments rely on the 6 minute walk distance as main outcome parameter although submaximal exercise performance reflects only one disease aspect.
Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigator intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters. New outcomes to be assessed will be home based activity monitoring, novel physiological measures, namely cerebral and muscle tissue oxygenation at rest and during exercise testing, stair ascent on mechanograph, sit to stand test and several serum markers and micro-RNA. All these assessments will be compared with hard endpoints events (death, lung-transplantation, hospitalization for PH), and with traditional outcome measures such as NYHA functional class, 6 minute walk distance, generic quality of life, cardiopulmonary exercise tests, sleep studies, health preference (utility) and cognitive function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PH target therapy | – | Other: PH target therapy according to physicianPatients receiving PH target therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with precapillary pulmonary hypertension classified according to WHO
Key inclusion criteria (3 listed)
- Patients with precapillary pulmonary hypertension
- Adult male and female patients of all ages referred to our center for evaluation/treatment of PH
- Written informed consent by the subject after information about the research project
Key exclusion criteria (3 listed)
- Patients with severe concomitant left heart disease (left ventricular ejection fraction <40%).
- Patients with restrictive lung disease (FVC<60% predicted); obstructive lung disease (forced expiratory volume (FEV) <60% predicted, with FEV 1/FVC<70%).
- Patients with any other disease limiting their ability to move (skeletal disease, neurological disease, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PH target therapy according to physicianPatients receiving PH target therapy | Other | PH target therapy |
Primary outcome
Survival
Time frame: 10 years
Transplant free survival will be registered
Change in the 6 minute walk distance
Time frame: 10 years
The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter
17 secondary outcomes
New York Heart association (NYHA) functional class
Time frame: 10 years
Score in health related Quality of Life (HRQoL) questionnaires
Time frame: 10 years
Hemodynamic parameters by echocardiography
Time frame: 10 years
Hospital days
Time frame: 10 years
red- and white blood cell counts
Time frame: 10 years
Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes
Time frame: 10 years
Score on Short-Form-6 D, Euro-Qol 5 D (EQ-5 D), visual analogue scale, time trade-off, standard gamble test
Time frame: 10 years
Overnight sleep study parameters
Time frame: 10 years
Score in cognitive function tests
Time frame: 10 years
Cardiopulmonary exercise test parameters
Time frame: 10 years
ECG parameters
Time frame: 10 years
Motion, step counts, metabolic equivalent
Time frame: 10 years
Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue
Time frame: 10 years
Time, maximal power in stair-ascent test
Time frame: 10 years
Performance in Sit to stand test
Time frame: 10 years
Level of C-reactive protein (CRP)
Time frame: 10 years
Level of N-terminal brain natriuretic peptide (BNP)
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 31263960Saxer S, Lichtblau M, Berlier C, Hasler ED, Schwarz EI, Ulrich S. Physical activity in incident patients with pulmonary arterial and chronic thromboembolic hypertension. Lung. 2019 Oct;197(5):617-625. doi: 10.1007/s00408-019-00248-x. Epub 2019 Jul 1.
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RecruitingObservational study
the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
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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.
Silvia Ulrich, MD principal investigator
University Hospital Zurich, Department of Pulmonology
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 Outcome Assessment, 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 3 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Ulrich, MD (++41442552220, pulmonalehypertonie@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02249806, which also lists 1 linked publication.
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 2 Nov 2022.