Pulmonary Hypertension Association Registry
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: 16-006061
Sponsor Protocol Number: 16-006061
About this study
The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. Baseline information will be collected at the time of initial evaluation at the PHCC with follow-up data collected at approximately 6-month intervals.
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
The PHAR will enroll patients who meet the following inclusion criteria:
- New patients to a PHA Care Center with either newly diagnosed or established PAH or CTEPH (within 6 months of first outpatient visit at the PHCC).
- Informed consent for data to be abstracted and included in the PHAR provided by the patient or guardian.
- Able to understand and speak either English or Spanish.
The PHAR includes only new participants at each center in an attempt to reduce problems that could arise from applying current guidelines to patients who were initially evaluated in the distant past. Focusing on new patients minimizes the burden of missing data and avoids the impression of practice deviations for patients evaluated in a different diagnostic and treatment era. The PHAR will enroll only the PAH and CTEPH subtypes of PH, given their similarity in treatment and diagnostic approach and the availability of consensus-based guidelines for quality care.
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 Robert Frantz, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available