A Study of Functional Class Self Report in Pulmonary Hypertension
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-004268
About this study
The purpose of this study is to evaluate the Pulmonary Hypertension Functional Class Self Report (PHFC-SR) ratings for a sample of subjects with pulmonary hypertension (PH).
A secondary purpose is to explore the concordance between the patient-reported PH-FC-SR and clinician-assessed World Health Organization Functional Classification (WHO-FC) measure in a sample of subjects with PH, and to assess the construct validity between the patient-reported PH-FC-SR and a patient-reported disease-specific measure and a general health-related quality of life (HRQOL) measure.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- ≥ 18 years of age.
- Subject must have a clinician-recorded diagnosis of Pulmonary Hypertension (PH).
- Subject must have either PAH (WHO Group 1), PH due to left heart disease (WHO Group 2), PH due to lung disease (WHO Group 3), PH due to blood clots in the lungs (WHO Group 4), or PH with unclear and/or multifactorial mechanisms (WHO Group 5) based on a clinician-reported diagnosis.
- Subject is able to read and complete an English-language electronic survey.
- Subject has access to a computer or tablet to complete the electronic survey.
- Subject is willing and able to provide electronic informed consent.
Exclusion Criteria:
Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Hilary DuBrock, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available