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Completed

NCT Number: NCT03905421

Quality of Life Assessed With the PAH SYMPACT Questionnaire

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quality of life in pulmonary hypertension subjects

    Time frame: 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

  2. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2019
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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