Zürich Pulmonary Hypertension Outcome Assessment Cohort
- Conditions
- Pulmonary Hypertension Outcome Assessment
- Interventions
- Other: PH target therapy according to physician
- Registration Number
- NCT02249806
- Lead Sponsor
- University of Zurich
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PH target therapy PH target therapy according to physician Patients receiving PH target therapy
- Primary Outcome Measures
Name Time Method Survival 10 years Transplant free survival will be registered
Change in the 6 minute walk distance 10 years The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter
- Secondary Outcome Measures
Name Time Method Hemodynamic parameters by echocardiography 10 years The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter
Hospital days 10 years Days spent in the hospital
Overnight sleep study parameters 10 years The change Overnight sleep study parameters will be registered at 3, 6, 12 months and yearly thereafter
Score in cognitive function tests 10 years The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter
Score in health related Quality of Life (HRQoL) questionnaires 10 years The change in HRQoL class will be registered at 3, 6, 12 months and yearly thereafter
New York Heart association (NYHA) functional class 10 years The change in NYHA class will be registered at 3, 6, 12 months and yearly thereafter
Score on Short-Form-6 D, Euro-Qol 5 D (EQ-5 D), visual analogue scale, time trade-off, standard gamble test 10 years The change in utility will be registered at 3, 6, 12 months and yearly thereafter
Cardiopulmonary exercise test parameters 10 years The change cardiopulmonary exercise test parameters will be registered at 3, 6, 12 months and yearly thereafter
ECG parameters 10 years The change in ECG parameters will be registered at 3, 6, 12 months and yearly thereafter
Motion, step counts, metabolic equivalent 10 years The change in Activity assessment parameters will be registered at 3, 6, 12 months and yearly thereafter with actigraphy
red- and white blood cell counts 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 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)
Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue 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 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 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) 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) 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)
Trial Locations
- Locations (1)
University Hospital Zürich
🇨🇭Zurich, Switzerland