Zürich Pulmonary Hypertension Outcome Assessment Cohort

NCT ID: NCT02249806

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2024-09-30

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.

Conditions

Pulmonary Hypertension Outcome Assessment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PH target therapy

Patients receiving PH target therapy

PH target therapy according to physician

Intervention Type: OTHER

Patients receiving PH target therapy

Interventions

PH target therapy according to physician

Patients receiving PH target therapy

Intervention Type: OTHER

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Ulrich, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Pulmonology

Locations

University Hospital Zürich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Silvia Ulrich, MD

Role: CONTACT

pulmonalehypertonie@usz.ch

++41442552220

Isabel Schmied

Role: CONTACT

pulmonalehypertonie@usz.ch

++41442552220

Facility Contacts

Silvia Ulrich, PD MD

Role: primary

silvia.ulrich@usz.ch

0041 44 255 22 20

References

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.

Reference Type: DERIVED

PMID: 31263960 (View on PubMed)

Other Identifiers

2014-0214_ZH PH Cohort

Identifier Type: -

Identifier Source: org_study_id