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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 : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Pulmonary Hypertension Outcome Assessment Other: PH target therapy according to physician

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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
PH target therapy
Patients receiving PH target therapy
 Other: PH target therapy according to physician
Patients receiving PH target therapy


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: 10 years ]
    Transplant free survival will be registered

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Hemodynamic parameters by echocardiography [ Time Frame: 10 years ]
    The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter

  4. Hospital days [ Time Frame: 10 years ]
    Days spent in the hospital

  5. 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

  6. 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)

  7. 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

  8. 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

  9. Score in cognitive function tests [ Time Frame: 10 years ]
    The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter

  10. 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

  11. ECG parameters [ Time Frame: 10 years ]
    The change in ECG parameters will be registered at 3, 6, 12 months and yearly thereafter

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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)

  17. 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
Venous blood will be collected for serum markers and micro-RNA

Eligibility Criteria
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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
Study Population
Patients with precapillary pulmonary hypertension classified according to WHO
Criteria

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.)
Contacts and Locations
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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): NCT02249806


Contacts
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Contact: Silvia Ulrich, MD ++41442552220 pulmonalehypertonie@usz.ch
Contact: Isabel Schmied ++41442552220 pulmonalehypertonie@usz.ch

Locations
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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         
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Silvia Ulrich, MD University Hospital Zurich, Department of Pulmonology
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02249806     History of Changes
Other Study ID Numbers: 2014-0214_ZH PH Cohort
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by University of Zurich:
Pulmonary Hypertension
Chronic thromboembolic pulmonary hypertension
Pulmonary arterial hypertension
Outcome
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases