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Clinical Trials/NCT03905421
NCT03905421
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country390 target enrollmentMarch 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension
Sponsor
Mayo Clinic
Enrollment
390
Locations
1
Primary Endpoint
Quality of life in pulmonary hypertension subjects
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 6, 2019
End Date
January 22, 2024
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hilary M. DuBrock, MD

Principal Investigator

Mayo Clinic

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

Outcomes

Primary Outcomes

Quality of life in pulmonary hypertension subjects

Time Frame: 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

Study Sites (1)

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