Quality of Life Assessed With the PAH SYMPACT Questionnaire

NCT ID: NCT03905421

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 390 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2024-01-22

Brief Summary

Researchers are evaluating quality of life in pulmonary hypertension subjects using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire and assessing the questionnaires' performance with regard to relationship to other markers of disease severity, response to treatment, and outcome in a clinical practice setting.

Detailed Description

Subjects will be recruited from among those seen at the Mayo Pulmonary Hypertension Clinic. The PAH-SYMPACT questionnaire will be administered either in written form or by telephone interview.

On the second 100 patients implement a standardized palliative care referral program for patients with Group 1 and 3 PH and high SYMPACT scores> 1.0.

Conditions

Pulmonary Hypertension

Study Design

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

Study Groups

usual care

The patient will be seen in the PH clinic and will be approached to consent and participate in the SYMPACT trial. They will not be randomized to palliative care.

No interventions assigned to this group

palliative care

The patient will be seen in the PH clinic and will be approached to consent and participate in the SYMPACT trial. Based on the patients in Group 1 and 3 PH and a high SYMPACT score\> 1.0 in any domain they will be randomized to receive standard care or a palliative care initial consult.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 18 years or above
• Consents to participate
• Documented group I PAH based upon these hemodynamic criteria: (mPAP > 20, PCW 18 or less, PVR > 3 Wood units
• Mean PAP > 20, PCW ≤ 18, PVR > 3 Wood units
• Parenchymal lung disease that in the opinion of the investigator qualifies patient as group III PH
• Documented chronic thromboembolic pulmonary hypertension or chronic thromboembolic disease with intent to treat with surgery, balloon pulmonary angioplasty, and/or PH medication

Exclusion Criteria

• Left sided heart disease (LVEF<50%, PAWP>18)
• Any other known concomitant life-threatening disease with a life expectancy <12 months
• Any other clinically relevant and/or serious chronic medical condition that would affect study participation in the opinion of the investigator
• Non English speaking

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

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Hilary M. DuBrock, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hilary M DuBrock, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

19-000630

Identifier Type: -

Identifier Source: org_study_id