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Quality of Life Assessed With the PAH SYMPACT Questionnaire

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03905421
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Hilary M DuBrock, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pulmonary Hypertension
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

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Mayo Clinic in Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

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