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A 10-Question survey could give brazilian pulmonary hypertension patients a voice in their care

NCT ID NCT07822997

Knowledge-focused Sponsor: Hospital de Clinicas de Porto Alegre Source: ClinicalTrials.gov ↗

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Cancelled before anyone took part.

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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When the status isn't known

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First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers at Hospital de Clínicas de Porto Alegre are translating and culturally adapting the EmPHasis-10 questionnaire, a short survey that measures how pulmonary hypertension affects patients' quality of life, into Brazilian Portuguese. The study enrolls 50 adults with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension who are clinically stable. Participants complete the new questionnaire along with the SF-36 health survey and frailty assessments, and researchers compare the results to check reliability and validity. The goal is to provide Brazilian doctors with a practical, culturally appropriate tool for tracking quality of life and guiding treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the Brazilian Portuguese version proves reliable, doctors in Brazil could use a short, low-cost questionnaire to track how pulmonary hypertension affects patients' daily lives and to guide treatment decisions.
What could go wrong
This is a small observational study of 50 patients at one hospital. The translated questionnaire may not perform as well as the original, and results may not apply to patients outside this clinic or to other types of pulmonary hypertension.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of patients diagnosed with pulmonary hypertension from clinical groups 1 and 4, according to the classification of the most recent World Symposium on Pulmonary Hypertension, who are followed on an outpatient basis at the Pulmonary Circulation Clinic of the Pulmonology Department of Hospital de Clínicas de Porto Alegre (HCPA). Patients will be consecutively recruited during the study period. A minimum disease duration or follow-up period of 6 months will be required.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

chronic thromboembolic pulmonary hypertension pulmonary arterial hypertension pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary hypertension Quality of life

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital de Clínicas de Porto Alegre

    RECRUITING

    Porto Alegre, Brazil

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