Pulmonary HypertensionEMPHASIS-10-BRNCT07822997
Quality of Life Questionnaire in Pulmonary Hypertension EMPHASIS-10: Brazilian Adaptation and Validation
An observational study of Pulmonary Hypertension and Quality of Life, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Quality of Life
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marcelo B Gazzana, MD, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre
55513359-6246, cep@hcpa.edu.br
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
LOGISTICS AND STUDY PROCEDURES The use of the EmPHasis-10 questionnaire was authorized by the Pulmonary Hypertension Association - United Kingdom (PHA-UK), the organization holding its copyright, and the translation process will be conducted in accordance with the guidelines provided by PHA-UK.
The translation process will initially consist of two independent translations into Brazilian Portuguese performed by two independent translators. Subsequently, the questionnaire will be back-translated into English by a third independent translator. All translations will be reviewed by a committee composed of three pulmonologists specialized in pulmonary circulation, members of the research team, and fluent in both languages.
A review report of the back-translation will be submitted to PHA-UK, which may provide suggestions that will be forwarded to the investigators for further adjustments, if necessary. After the final version is established, the questionnaire will be pilot-tested in five patients. After completing the questionnaire, these patients will be asked about comprehension of each EmPHasis-10-BR item using the following questions: Was this item understood? What does this item mean? Can this item be explained in different words? Can alternative wording be suggested? A report based on this pilot study will be prepared and reviewed by pulmonary hypertension specialists to identify any additional adjustments that may be required.
After finalization, patients who meet the eligibility criteria will undergo collection of demographic data and information related to health status, comorbidities, symptoms, and complementary test results. Eligible patients will be invited to participate during outpatient clinic visits and will be referred to the Pulmonology Department after completion of the routine appointment to initiate study procedures.
At the first study visit, after signing the written informed consent form, the EmPHasis-10-BR questionnaire will be administered by a trained interviewer. Test-retest reliability will be assessed through an in-person reassessment conducted 7 to 14 days later at the Pulmonology Department. During this second visit, after administration of the EmPHasis-10-BR, participants will also complete the CAMPHOR questionnaire, the SF-36 questionnaire and the Fried Frailty Phenotype criteria.
A third contact will be conducted by telephone 7 to 14 days after Visit 2 to validate the questionnaire for remote administration.
In addition, routine clinical data used for pulmonary hypertension risk stratification will be collected through medical record review, in accordance with standard outpatient care at the Pulmonary Circulation Clinic. These data will include laboratory tests, echocardiography, six-minute walk test, cardiopulmonary exercise testing, cardiac magnetic resonance imaging, and right heart catheterization results.
All collected data will be entered into a Google Sheets® database by a single investigator.
STUDY VARIABLES Independent variables: demographic data; smoking history and smoking index; anthropometric measurements; comorbidities; medications; NYHA functional class; pulmonary hypertension etiology and group; ESC risk stratification; complementary test results.
Dependent variable: EmPHasis-10-BR score.
STATISTICAL ANALYSIS Quantitative variables will be expressed as mean ± standard deviation or median and interquartile range, according to data distribution. The Shapiro-Wilk test will be used to assess normality. Qualitative variables will be expressed as percentages, and 95% confidence intervals will be calculated when appropriate.
Internal consistency of the EmPHasis-10-BR will be evaluated using Cronbach's alpha. Values below 0.7 will be considered indicative of insufficient internal consistency. Item-total correlations are expected to range between 0.2 and 0.8.
Test-retest reliability will be assessed by correlating EmPHasis-10-BR scores obtained at different time points (Visit 1 and Visit 2), assuming no clinical change occurred between administrations. A minimum correlation coefficient of 0.85 will be required to indicate adequate reliability, using Spearman's correlation test. A similar analysis will be performed comparing in-person (Visit 2) and remote (Visit 3) administrations.
Additionally, EmPHasis-10-BR scores will be compared with general and disease-specific quality-of-life questionnaires validated in Portuguese, namely the 36-item Short Form Health Survey (SF-36) and the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR).
All statistical tests will be two-tailed, and p values < 0.05 will be considered statistically significant. Data will be analyzed using the Statistical Package for the Social Sciences (SPSS), version 18.0 for Windows (SPSS Inc., Chicago, IL, USA).
RISKS The potential risks associated with participation in this study include unauthorized disclosure or identification of patient-related data. However, all measures to ensure confidentiality will be adopted. The investigators commit to preserving participants' privacy throughout the study and to using all collected information solely for the execution of this research project.
BENEFITS The expected benefits of this study include the validation of the EmPHasis-10 questionnaire for use in Brazilian Portuguese, aiming to standardize clinical assessment and generate reliable data for longitudinal follow-up. Additionally, the instrument may support non-invasive, low-cost risk stratification and prognostic assessment, with potential applicability across different levels of healthcare.
- Conditions
- Pulmonary Hypertension, Quality of Life
- Keywords
- pulmonary hypertension, quality of life, questionnaire validation
- Medical subject headings
- Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal consistency of the EmPHasis-10-BR questionnaire measured by Cronbach's alpha
EmPHasis-10 Brazilian Portuguese version (EmPHasis-10-BR): Evaluates health-related quality of life in pulmonary hypertension. Scores range from 0 to 50, where higher scores indicate a worse outcome (greater disease impact/lower quality of life).
Measured: 7-28 days
Test-retest reliability measured by Spearman's correlation coefficient
Measured: 7-28 days
Concurrent validity assessed by correlation with SF-36 questionnaire
Concurrent validity considering the SF-36 (Brazilian Portuguese version), a generic questionnaire of 36 items evaluating health-related quality of life across 8 domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) and 2 summary component scores (PCS and MCS). Transformed scores for each domain/component range from 0 to 100, where higher scores indicate a better outcome (better overall health status and higher quality of life).
Measured: 7-28 days
Secondary outcomes (23)
Concurrent validity of the EmPHasis-10-BR questionnaire measured by correlation with SF-36 scores
Concurrent validity of the EmPHasis-10 Brazilian Portuguese version (EmPHasis-10-BR) will be evaluated by assessing its correlation with the 36-Item Short Form Health Survey (SF-36) using the Spearman rank correlation coefficient. 1) EmPHasis-10-BR: A disease-specific questionnaire evaluating health-related quality of life in pulmonary hypertension. Total scores range from 0 to 50, where higher scores indicate a worse outcome (greater disease impact and lower quality of life). 2) SF-36 (Brazilian Portuguese version): A generic questionnaire of 36 items evaluating health-related quality of life across 8 domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) and 2 summary component scores (PCS and MCS). Correlation values range from -1.0 (perfect negative correlation) to +1.0 (perfect positive correlation).
Measured: Between enrollment to 7-28 days
Correlation between age and EmPHasis-10-BR score
Participant age, measured in years, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis
Measured: Between enrollment to 7-28 days
Test-retest reliability of the EmPHasis-10-BR questionnaire when administered remotely, measured by correlation coefficients
EmPHasis-10 Brazilian Portuguese version (EmPHasis-10-BR): Evaluates health-related quality of life in pulmonary hypertension. Scores range from 0 to 50, where higher scores indicate a worse outcome (greater disease impact/lower quality of life).
Measured: Between enrollment to 7-28 days
Correlation between EmPHasis-10-BR scores and FRAIL-BR scores
The correlation between health-related quality of life and frailty will be assessed using the Spearman's correlation coefficient. 1) EmPHasis-10 Brazilian Portuguese version (EmPHasis-10-BR): Evaluates health-related quality of life in pulmonary hypertension. Scores range from 0 to 50, where higher scores indicate a worse outcome (greater disease impact/lower quality of life). 2) FRAIL Scale - Brazilian Portuguese version (FRAIL-BR): Assesses physical frailty based on 5 components (Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight). Total scores range from 0 to 5, where 0 = robust, 1-2 = pre-frail, and 3-5 = frail. Higher scores indicate a worse outcome (greater degree of frailty). Correlation values range from -1.0 (perfect negative correlation) to +1.0 (perfect positive correlation).
Measured: Between enrollment to 7-28 days
Correlation between EmPHasis-10-BR scores and the Fried Frailty Phenotype Criteria scores
The correlation between health-related quality of life and frailty will be assessed using the Spearman's correlation coefficient. 1) EmPHasis-10 Brazilian Portuguese version (EmPHasis-10-BR): Evaluates health-related quality of life in pulmonary hypertension. Scores range from 0 to 50, where higher scores indicate a worse outcome (greater disease impact/lower quality of life). 2) Fried Frailty Phenotype Criteria: Assesses physical frailty across 5 criteria (unintentional weight loss, weakness/grip strength, exhaustion, slowness/gait speed, and low physical activity). Total scores range from 0 to 5, where 0 = robust, 1-2 = pre-frail, and 3-5 = frail. Higher scores indicate a worse outcome (greater degree of frailty). Correlation values range from -1.0 (perfect negative correlation) to +1.0 (perfect positive correlation).
Measured: Between enrollment to 7-28 days
Comparison of EmPHasis-10-BR scores across age categories
EmPHasis-10-BR total scores will be compared across three age categories: <50 years, 50-64 years, and ≥65 years. Age is measured in years. The Kruskal-Wallis test will be used when the distribution is non-normal, and one-way ANOVA will be used when the assumptions of normality and homoscedasticity are reasonably met.
Measured: 7-28 days
Comparison of EmPHasis-10-BR scores by gender
EmPHasis-10-BR total scores will be compared between male and female participants. Gender will be categorized as male or female. The Mann-Whitney U test will be used for non-normally distributed scores, and the independent-samples t-test will be used when the assumptions of normality and homoscedasticity are reasonably met.
Measured: 7-28 days
Comparison of EmPHasis-10-BR scores by modified NYHA functional class for pulmonary hypertension
EmPHasis-10-BR total scores will be compared between participants classified as functional class I-II and III-IV according to the modified New York Heart Association (NYHA) functional classification for pulmonary hypertension. The Mann-Whitney U test will be used for non-normally distributed scores, and the independent-samples t-test will be used when the assumptions of normality and homoscedasticity are reasonably met.
Measured: 7-28 days
Comparison of EmPHasis-10-BR scores across ESC risk stratification categories
EmPHasis-10-BR total scores will be compared across three pulmonary hypertension risk categories according to the European Society of Cardiology (ESC) risk stratification: low risk, intermediate risk, and high risk. The Kruskal-Wallis test will be used for non-normally distributed scores, and one-way ANOVA will be used when the assumptions of normality and homoscedasticity are reasonably met.
Measured: 7-28 days
Comparison of EmPHasis-10-BR scores across four ESC risk stratification categories
EmPHasis-10-BR total scores will be compared across four pulmonary hypertension risk categories according to the European Society of Cardiology (ESC) risk stratification: low risk, intermediate-low risk, intermediate-high risk, and high risk. The Kruskal-Wallis test will be used for non-normally distributed scores, and one-way ANOVA will be used when the assumptions of normality and homoscedasticity are reasonably met.
Measured: 7-28 days
orrelation between six-minute walk test distance and EmPHasis-10-BR score
Six-minute walk test distance, measured in meters, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis. A multivariable linear regression model will also be performed with the EmPHasis-10-BR total score as the dependent variable and six-minute walk test distance as the primary independent variable, adjusting for potential confounders including age, sex, WHO functional class, pulmonary hypertension etiology, BNP/NT-proBNP level, pulmonary artery pressure, and cardiac output.
Measured: 7- 28 days
Correlation between echocardiographic pulmonary artery systolic pressure and EmPHasis-10-BR score
Echocardiographic pulmonary artery systolic pressure (PASP), measured in mmHg, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Correlation between echocardiographic TAPSE/PASP ratio and EmPHasis-10-BR score
The echocardiographic tricuspid annular plane systolic excursion to pulmonary artery systolic pressure ratio (TAPSE/PASP), measured in mm/mmHg, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Correlation between echocardiographic right atrial area and EmPHasis-10-BR score
Echocardiographic right atrial area, measured in cm², will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis
Measured: 7-28days
Correlation between cardiac magnetic resonance right ventricular ejection fraction and EmPHasis-10-BR score
Right ventricular ejection fraction (RVEF), assessed by cardiac magnetic resonance imaging and expressed as a percentage, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Correlation between cardiac magnetic resonance right atrial area and EmPHasis-10-BR score
Right atrial area, assessed by cardiac magnetic resonance imaging and measured in cm², will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7- 28 days
Correlation between peak oxygen uptake and EmPHasis-10-BR score
Peak oxygen uptake (VO₂ peak), assessed by cardiopulmonary exercise testing and expressed in mL/kg/min, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Correlation between VE/VCO₂ slope and EmPHasis-10-BR score
The VE/VCO₂ slope, assessed by cardiopulmonary exercise testing and expressed in L/L, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Correlation between peak oxygen pulse and EmPHasis-10-BR score
Peak oxygen pulse, assessed by cardiopulmonary exercise testing and expressed in mL/beat, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Correlation between mean pulmonary artery pressure and EmPHasis-10-BR score
ean pulmonary artery pressure, measured by right heart catheterization and expressed in mmHg, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Correlation between right atrial pressure and EmPHasis-10-BR score
Right atrial pressure, measured by right heart catheterization and expressed in mmHg, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Correlation between cardiac index and EmPHasis-10-BR score
Cardiac index, measured by right heart catheterization and expressed in L/min/m², will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Correlation between pulmonary vascular resistance and EmPHasis-10-BR score
Pulmonary vascular resistance, measured by right heart catheterization and expressed in Wood units, will be evaluated in relation to the total score of the EmPHasis-10-BR questionnaire using Spearman rank correlation and linear regression analysis.
Measured: 7-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Basso Gazzana, Hospital de Clinicas de Porto Alegre
- Investigators
- Marcelo B Gazzana, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822997
- Sponsor's protocol ID
- 92342325.9.0000.5327
- Acronym
- EMPHASIS-10-BR
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07822997
- Acronym / sponsor ID
- EMPHASIS-10-BR / 92342325.9.0000.5327
- Conditions
- Pulmonary Hypertension, Quality of Life
- Keywords
- pulmonary hypertension, quality of life, questionnaire validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
LOGISTICS AND STUDY PROCEDURES The use of the EmPHasis-10 questionnaire was authorized by the Pulmonary Hypertension Association - United Kingdom (PHA-UK), the organization holding its copyright, and the translation process will be conducted in accordance with the guidelines provided by PHA-UK.
The translation process will initially consist of two independent translations into Brazilian Portuguese performed by two independent translators. Subsequently, the questionnaire will be back-translated into English by a third independent translator. All translations will be reviewed by a committee composed of three pulmonologists specialized in pulmonary circulation, members of the research team, and fluent in both languages.
A review report of the back-translation will be submitted to PHA-UK, which may provide suggestions that will be forwarded to the investigators for further adjustments, if necessary. After the final version is established, the questionnaire will be pilot-tested in five patients. After completing the questionnaire, these patients will be asked about comprehension of each EmPHasis-10-BR item using the following questions: Was this item understood? What does this item mean? Can this item be explained in different words? Can alternative wording be suggested? A report based on this pilot study will be prepared and reviewed by pulmonary hypertension specialists to identify any additional adjustments that may be required.
After finalization, patients who meet the eligibility criteria will undergo collection of demographic data and information related to health status, comorbidities, symptoms, and complementary test results. Eligible patients will be invited to participate during outpatient clinic visits and will be referred to the Pulmonology Department after completion of the routine appointment to initiate study procedures.
At the first study visit, after signing the written informed consent form, the EmPHasis-10-BR questionnaire will be administered by a trained interviewer. Test-retest reliability will be assessed through an in-person reassessment conducted 7 to 14 days later at the Pulmonology Department. During this second visit, after administration of the EmPHasis-10-BR, participants will also complete the CAMPHOR questionnaire, the SF-36 questionnaire and the Fried Frailty Phenotype criteria.
A third contact will be conducted by telephone 7 to 14 days after Visit 2 to validate the questionnaire for remote administration.
In addition, routine clinical data used for pulmonary hypertension risk stratification will be collected through medical record review, in accordance with standard outpatient care at the Pulmonary Circulation Clinic. These data will include laboratory tests, echocardiography, six-minute walk test, cardiopulmonary exercise testing, cardiac magnetic resonance imaging, and right heart catheterization results.
All collected data will be entered into a Google Sheets® database by a single investigator.
STUDY VARIABLES Independent variables: demographic data; smoking history and smoking index; anthropometric measurements; comorbidities; medications; NYHA functional class; pulmonary hypertension etiology and group; ESC risk stratification; complementary test results.
Dependent variable: EmPHasis-10-BR score.
STATISTICAL ANALYSIS Quantitative variables will be expressed as mean ± standard deviation or median and interquartile range, according to data distribution. The Shapiro-Wilk test will be used to assess normality. Qualitative variables will be expressed as percentages, and 95% confidence intervals will be calculated when appropriate.
Internal consistency of the EmPHasis-10-BR will be evaluated using Cronbach's alpha. Values below 0.7 will be considered indicative of insufficient internal consistency. Item-total correlations are expected to range between 0.2 and 0.8.
Test-retest reliability will be assessed by correlating EmPHasis-10-BR scores obtained at different time points (Visit 1 and Visit 2), assuming no clinical change occurred between administrations. A minimum correlation coefficient of 0.85 will be required to indicate adequate reliability, using Spearman's correlation test. A similar analysis will be performed comparing in-person (Visit 2) and remote (Visit 3) administrations.
Additionally, EmPHasis-10-BR scores will be compared with general and disease-specific quality-of-life questionnaires validated in Portuguese, namely the 36-item Short Form Health Survey (SF-36) and the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR).
All statistical tests will be two-tailed, and p values < 0.05 will be considered statistically significant. Data will be analyzed using the Statistical Package for the Social Sciences (SPSS), version 18.0 for Windows (SPSS Inc., Chicago, IL, USA).
RISKS The potential risks associated with participation in this study include unauthorized disclosure or identification of patient-related data. However, all measures to ensure confidentiality will be adopted. The investigators commit to preserving participants' privacy throughout the study and to using all collected information solely for the execution of this research project.
BENEFITS The expected benefits of this study include the validation of the EmPHasis-10 questionnaire for use in Brazilian Portuguese, aiming to standardize clinical assessment and generate reliable data for longitudinal follow-up. Additionally, the instrument may support non-invasive, low-cost risk stratification and prognostic assessment, with potential applicability across different levels of healthcare.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internal consistency of the EmPHasis-10-BR questionnaire measured by Cronbach's alpha
Time frame: 7-28 days
EmPHasis-10 Brazilian Portuguese version (EmPHasis-10-BR): Evaluates health-related quality of life in pulmonary hypertension. Scores range from 0 to 50, where higher scores indicate a worse outcome (greater disease impact/lower quality of life).
Test-retest reliability measured by Spearman's correlation coefficient
Time frame: 7-28 days
Concurrent validity assessed by correlation with SF-36 questionnaire
Time frame: 7-28 days
Concurrent validity considering the SF-36 (Brazilian Portuguese version), a generic questionnaire of 36 items evaluating health-related quality of life across 8 domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) and 2 summary component scores (PCS and MCS). Transformed scores for each domain/component range from 0 to 100, where higher scores indicate a better outcome (better overall health status and higher quality of life).
23 secondary outcomes
Concurrent validity of the EmPHasis-10-BR questionnaire measured by correlation with SF-36 scores
Time frame: Between enrollment to 7-28 days
Correlation between age and EmPHasis-10-BR score
Time frame: Between enrollment to 7-28 days
Test-retest reliability of the EmPHasis-10-BR questionnaire when administered remotely, measured by correlation coefficients
Time frame: Between enrollment to 7-28 days
Correlation between EmPHasis-10-BR scores and FRAIL-BR scores
Time frame: Between enrollment to 7-28 days
Correlation between EmPHasis-10-BR scores and the Fried Frailty Phenotype Criteria scores
Time frame: Between enrollment to 7-28 days
Comparison of EmPHasis-10-BR scores across age categories
Time frame: 7-28 days
Comparison of EmPHasis-10-BR scores by gender
Time frame: 7-28 days
Comparison of EmPHasis-10-BR scores by modified NYHA functional class for pulmonary hypertension
Time frame: 7-28 days
Comparison of EmPHasis-10-BR scores across ESC risk stratification categories
Time frame: 7-28 days
Comparison of EmPHasis-10-BR scores across four ESC risk stratification categories
Time frame: 7-28 days
orrelation between six-minute walk test distance and EmPHasis-10-BR score
Time frame: 7- 28 days
Correlation between echocardiographic pulmonary artery systolic pressure and EmPHasis-10-BR score
Time frame: 7-28 days
Correlation between echocardiographic TAPSE/PASP ratio and EmPHasis-10-BR score
Time frame: 7-28 days
Correlation between echocardiographic right atrial area and EmPHasis-10-BR score
Time frame: 7-28days
Correlation between cardiac magnetic resonance right ventricular ejection fraction and EmPHasis-10-BR score
Time frame: 7-28 days
Correlation between cardiac magnetic resonance right atrial area and EmPHasis-10-BR score
Time frame: 7- 28 days
Correlation between peak oxygen uptake and EmPHasis-10-BR score
Time frame: 7-28 days
Correlation between VE/VCO₂ slope and EmPHasis-10-BR score
Time frame: 7-28 days
Correlation between peak oxygen pulse and EmPHasis-10-BR score
Time frame: 7-28 days
Correlation between mean pulmonary artery pressure and EmPHasis-10-BR score
Time frame: 7-28 days
Correlation between right atrial pressure and EmPHasis-10-BR score
Time frame: 7-28 days
Correlation between cardiac index and EmPHasis-10-BR score
Time frame: 7-28 days
Correlation between pulmonary vascular resistance and EmPHasis-10-BR score
Time frame: 7-28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcelo B Gazzana, MD, PhD contact
Marcelo B Gazzana, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Quality of Life, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruna H Bianchini, MD (55+ 48 991023563, bhbianchini@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal consistency of the EmPHasis-10-BR questionnaire measured by Cronbach's alpha (time frame: 7-28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.