Brazilian Portuguese version of EmPHasis-10 for pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a cross-sectional observational study to translate, culturally adapt, and validate the EmPHasis-10 quality-of-life questionnaire for Brazilian patients with precapillary pulmonary hypertension (PAH and CTEPH). The process includes forward translations, back-translation, expert review, pilot testing, and final adjustments guided by PHA-UK guidelines. Fifty adult patients will be recruited from the Pulmonary Circulation Outpatient Clinic at Hospital de Clínicas de Porto Alegre, with inclusion criteria focusing on native Brazilian Portuguese speakers who are clinically stable and on confirmed diagnoses. The study aims to establish the Brazilian Portuguese version's reliability, validity, and comprehension to support local risk stratification and patient-centered care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital de Clínicas de Porto Alegre
  Porto Alegre, Brazil Recruiting

Study contacts

• Principal investigator: Marcelo B Gazzana, MD, PhD — Hospital de Clinicas de Porto Alegre
• Study coordinator: Bruna H Bianchini, MD
• Email: bhbianchini@hcpa.edu.br
• Phone: 55+ 48 991023563

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.