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Quality of Life Questionnaire in Pulmonary Hypertension EMPHASIS-10: Brazilian Adaptation and Validation

Recruitingn/aAges 18 Years - anyAllHospital de Clinicas de Porto Alegre
NCT07822997 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pulmonary hypertension (PH) is a severe and heterogeneous condition associated with poor prognosis and significant impairment in quality of life. Patient-reported outcome questionnaires are useful, low-cost tools for clinical assessment and risk stratification. The EmPHasis-10 questionnaire is a brief and easy-to-administer instrument that has demonstrated good correlation with clinical outcomes across different PH populations; however, a validated Brazilian Portuguese version is not yet available. This study aims to translate, culturally adapt, and validate the EmPHasis-10 questionnaire for Brazilian patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The investigators designed a cross-sectional observational study including 50 adult patients with a confirmed diagnosis of PAH (group 1) or CTEPH (group 4), followed at the Pulmon

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📋 Eligibility rules (as published)
Inclusion Criteria: * Willingness to participate in the study after being informed and having provided written informed consent; * Age ≥ 18 years; * Diagnosis of precapillary pulmonary hypertension from groups 1 and 4, confirmed by right heart catheterization; * Clinically stable patients with no changes in therapy for at least 3 months; * Native speaker of Brazilian Portuguese; * Literate patient. Exclusion Criteria: * Diagnosis of pulmonary hypertension from groups 2, 3, and/or 5; * Spirometry showing forced vital capacity (FVC) ≤ 70% predicted and/or forced expiratory volume in the first second (FEV₁) ≤ 60% predicted; * Severe communication impairment, including major cognitive deficit or severe hearing or visual impairment, resulting in inability to respond to the questionnaires or to understand the study procedures; * Patients who experience clinical exacerbation or worsening between the days on which the questionnaires are administered; * Refusal to participate in the study.
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What it tests

  • Not listed
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Where

1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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