Quality of Life Assessed With the PAH SYMPACT Questionnaire

Quality of Life Assessed With the PAH SYMPACT Questionnaire in the Pulmonary Hypertension Clinic

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03905421

Enrollment

390

Registered

2019-04-05

Start date

2019-03-06

Completion date

2024-01-22

Last updated

2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of life in pulmonary hypertension subjects	Baseline	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

Countries

United States

Outcome results