Quality of Life Assessed With the PAH SYMPACT Questionnaire

NCT03905421 | Completed

• 1 other identifier: 19-000630
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• Quality of life in pulmonary hypertension subjects

  Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire using a scale of 0=no, 1=mild, 2=moderate, 3=severe, and 4=very severe

  Baseline

• Quality of life in pulmonary hypertension subjects

  Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire using a scale of 0=no, 1=mild, 2=moderate, 3=severe, and 4=very severe

  14 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from among those seen at the Mayo Pulmonary Hypertension Clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hilary M DuBrock, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: April 5, 2019
• Study Start: March 6, 2019
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)