Zürich Pulmonary Hypertension Outcome Assessment Cohort (ZHPHCohort)
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ClinicalTrials.gov Identifier: NCT02249806 |
Recruitment Status :
Recruiting
First Posted : September 26, 2014
Last Update Posted : November 6, 2020
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Condition or disease | Intervention/treatment |
---|---|
Pulmonary Hypertension Outcome Assessment | Other: PH target therapy according to physician |
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 Type : | Observational [Patient Registry] |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 10 Years |
Official Title: | Zürich Pulmonary Hypertension Outcome Assessment Cohort |
Study Start Date : | September 2014 |
Estimated Primary Completion Date : | September 2024 |
Estimated Study Completion Date : | September 2024 |

Group/Cohort | Intervention/treatment |
---|---|
PH target therapy
Patients receiving PH target therapy
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Other: PH target therapy according to physician
Patients receiving PH target therapy |
- 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
- New York Heart association (NYHA) functional class [ Time Frame: 10 years ]The change in NYHA class will be registered at 3, 6, 12 months and yearly thereafter
- Score in health related Quality of Life (HRQoL) questionnaires [ Time Frame: 10 years ]The change in HRQoL class will be registered at 3, 6, 12 months and yearly thereafter
- Hemodynamic parameters by echocardiography [ Time Frame: 10 years ]The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter
- Hospital days [ Time Frame: 10 years ]Days spent in the hospital
- red- and white blood cell counts [ Time Frame: 10 years ]The change in blood cell count will be registered at 3, 6, 12 months and yearly thereafter
- Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes [ Time Frame: 10 years ]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)
- 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 ]The change in utility will be registered at 3, 6, 12 months and yearly thereafter
- Overnight sleep study parameters [ Time Frame: 10 years ]The change Overnight sleep study parameters will be registered at 3, 6, 12 months and yearly thereafter
- Score in cognitive function tests [ Time Frame: 10 years ]The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter
- Cardiopulmonary exercise test parameters [ Time Frame: 10 years ]The change cardiopulmonary exercise test parameters will be registered at 3, 6, 12 months and yearly thereafter
- ECG parameters [ Time Frame: 10 years ]The change in ECG parameters will be registered at 3, 6, 12 months and yearly thereafter
- Motion, step counts, metabolic equivalent [ Time Frame: 10 years ]The change in Activity assessment parameters will be registered at 3, 6, 12 months and yearly thereafter with actigraphy
- Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue [ Time Frame: 10 years ]Changes in cerebral and muscle tissue oxygenation will be assessed after 3, 6, 12 months and yearly thereafter by Near-infrared-Spectroscopy
- Time, maximal power in stair-ascent test [ Time Frame: 10 years ]Changes in performance of stair ascent test will be assessed after 3, 6, 12 months and yearly thereafter
- Performance in Sit to stand test [ Time Frame: 10 years ]Changes in sit- to stand test will be assessed after 3, 6, 12 months and yearly thereafter
- Level of C-reactive protein (CRP) [ Time Frame: 10 years ]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)
- Level of N-terminal brain natriuretic peptide (BNP) [ Time Frame: 10 years ]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)
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)

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): NCT02249806
Contact: Silvia Ulrich, MD | ++41442552220 | pulmonalehypertonie@usz.ch | |
Contact: Isabel Schmied | ++41442552220 | pulmonalehypertonie@usz.ch |
Switzerland | |
University Hospital Zürich | Recruiting |
Zurich, Switzerland, 8091 | |
Contact: Silvia Ulrich, PD MD 0041 44 255 22 20 silvia.ulrich@usz.ch | |
Principal Investigator: Silvia Ulrich, MD |
Principal Investigator: | Silvia Ulrich, MD | University Hospital Zurich, Department of Pulmonology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT02249806 |
Other Study ID Numbers: |
2014-0214_ZH PH Cohort |
First Posted: | September 26, 2014 Key Record Dates |
Last Update Posted: | November 6, 2020 |
Last Verified: | November 2020 |
Pulmonary Hypertension Chronic thromboembolic pulmonary hypertension Pulmonary arterial hypertension Outcome |
Hypertension, Pulmonary Hypertension Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |