NCT07822997Recruiting
Quality of Life Questionnaire in Pulmonary Hypertension EMPHASIS-10: Brazilian Adaptation and Validation
Cultural Adaptation, Validation, and Reliability of the EMPHASIS-10 Questionnaire for Assessing Quality of Life in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension: Brazilian Version
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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 Pulmonary Circulation Outpatient Clinic of Hospital de Clínicas de Porto Alegre. The EmPHasis-10-BR will be administered alongside the SF-36 questionnaire for concurrent validity analysis, as well as frailty assessment instruments. Reliability will be evaluated through test-retest analysis in both in-person and remote settings. Clinical, functional, and hemodynamic variables will also be collected to investigate associations between EmPHasis-10-BR scores and risk stratification parameters recommended by international guidelines. Statistical analyses will include Cronbach's alpha to assess internal consistency, Spearman's correlation coefficients for test-retest reliability, and comparisons with previously validated instruments. The investigators expect that the validation of the EmPHasis-10-BR will provide a practical, reliable, and culturally appropriate tool for quality-of-life assessment in Brazilian patients with PH, supporting standardized clinical follow-up, risk stratification, and potentially contributing to therapeutic decision-making.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 22 Dec 2025
- Start date
- 1 Mar 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- NCT number
- NCT07822997
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Mar 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of pulmonary hypertension from groups 2, 3, and/or 5;
- 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;
Other
- Spirometry showing forced vital capacity (FVC) ≤ 70% predicted and/or forced expiratory volume in the first second (FEV₁) ≤ 60% predicted;
- Patients who experience clinical exacerbation or worsening between the days on which the questionnaires are administered;
- Refusal to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.