Quality of Life Assessed With the PAH SYMPACT Questionnaire

Active, not recruiting

• Conditions: Pulmonary Hypertension

• Registration Number: NCT03905421
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2019-03-06
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-31
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 390

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life in pulmonary hypertension subjects	14 months	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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States