Pulmonary Arterial Hypertension (PAH)PROPULSE-SchNCT07453030
Long-Term Outcomes of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension (PAH), run by Caio Júlio César dos Santos Fernandes at 1 site in Brazil.
Trial summary
Schistosomiasis-associated pulmonary arterial hypertension is a serious condition that can lead to shortness of breath, heart failure, frequent hospitalizations, and early death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2026to 1 Mar 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 includes adult patients with schistosomiasis-associated pulmonary arterial hypertension (PAH-Sch) followed at a specialized pulmonary hypertension referral center. The population comprises two observational cohorts: patients who initiated oral selexipag as part of routine clinical care and a mirror cohort of clinically similar patients who did not receive selexipag prior to its availability at the center. All patients have confirmed pre-capillary pulmonary arterial hypertension and stable background therapy at the index date. Participants are followed longitudinally using data obtained from routine clinical practice to assess long-term clinical outcomes. No study-mandated interventions are performed.
Who may be able to join
- Adults aged 18 years or older.
- Confirmed diagnosis of pulmonary arterial hypertension associated with schistosomiasis (PAH-Sch).
- Diagnosis of pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization, performed at any time prior to the index date (T0), as documented in the medical record.
- Evidence of schistosomiasis infection, including epidemiological history and ultrasonographic findings compatible with hepatosplenic schistosomiasis.
- Previous antiparasitic treatment for schistosomiasis.
- Clinical stability at the index date, defined as absence of progressive right heart failure or clinical worsening within the previous 12 weeks.
Show all 10Show fewer
- World Health Organization (WHO) functional class I-III at the index date.
- Stable background pulmonary arterial hypertension-specific therapy with a phosphodiesterase-5 inhibitor and/or endothelin receptor antagonist for at least 12 weeks prior to the index date.
- For the treated cohort: initiation of oral selexipag as part of routine clinical care.
- For the mirror cohort: eligibility for therapeutic escalation at the index date without exposure to selexipag.
Who cannot join
- World Health Organization (WHO) functional class IV at the index date.
- Progressive right heart failure or clinical deterioration within the 12 weeks prior to the index date.
- Documented formal contraindication to selexipag in the medical record.
- Insufficient baseline data at the index date to allow clinical characterization or inclusion in propensity score analyses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo
São Paulo, São Paulo, 05403-900
About this study
Official title: PROPULSE-Sch: Long-Term Evaluation of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension Using a Propensity Score-Matched Mirror Cohort
Schistosomiasis-associated pulmonary arterial hypertension is a serious condition that can lead to shortness of breath, heart failure, frequent hospitalizations, and early death. Although treatments for pulmonary arterial hypertension have improved over time, patients with this specific cause of the disease are often not included in long-term studies.
Selexipag is an oral medication used to treat pulmonary arterial hypertension and is part of routine clinical care in Brazil. Its long-term effects in patients with schistosomiasis-associated pulmonary arterial hypertension are not well understood.
Read more
The PROPULSE-Sch study aims to evaluate long-term clinical outcomes in patients with schistosomiasis-associated pulmonary arterial hypertension who received selexipag, compared with similar patients who did not receive this medication before it became available at the study center.
This is an observational study using data from routine medical care. All treatments are prescribed by the treating physicians, and participation in the study does not change patient care. The results may help improve understanding of long-term outcomes and support treatment decisions in this population.
Read the detailed description
Schistosomiasis-associated pulmonary arterial hypertension (PAH-Sch) is a prevalent cause of pulmonary arterial hypertension in endemic regions and is associated with significant morbidity and premature mortality. Despite advances in targeted therapies for pulmonary arterial hypertension, patients with PAH-Sch remain underrepresented in long-term studies, particularly in real-world clinical settings.
Selexipag, an oral selective prostacyclin IP receptor agonist, has demonstrated clinical and hemodynamic benefits in pulmonary arterial hypertension. Following its incorporation into routine clinical practice in Brazil, selexipag has been increasingly used in eligible patients with PAH-Sch. However, evidence regarding its long-term outcomes in this specific population is limited.
PROPULSE-Sch is a single-center, observational, longitudinal study with an ambispective design, combining retrospective data and prospective follow-up. The study evaluates long-term clinical outcomes associated with exposure to selexipag in patients with PAH-Sch, compared with a mirror cohort of clinically similar patients who did not receive selexipag prior to its availability at the center. To reduce confounding and indication bias inherent to observational comparisons, analyses are conducted using propensity score matching.
All treatment decisions, including initiation and intensification of therapy, are made exclusively by the treating physicians as part of routine clinical care. The study does not mandate any intervention, treatment assignment, or protocol-driven management. Data are obtained from medical records and standard follow-up visits. By using real-world data and robust observational methods, this study aims to contribute clinically relevant evidence on long-term outcomes in schistosomiasis-associated pulmonary arterial hypertension.
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- Pulmonary Arterial Hypertension, Schistosomiasis, Prostacyclin Pathway, Real-World Evidence, Propensity Score Matching, Long-Term Outcomes, Observational Study
- Medical subject headings
- Pulmonary Arterial Hypertension, Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Selexipag-Treated PAH-Sch Cohort | Adult patients with schistosomiasis-associated pulmonary arterial hypertension who initiated oral selexipag as part of routine clinical care. The index date (T0) is defined as the date of selexipag initiation recorded in the medical record. Patients are followed longitudinally to assess long-term clinical outcomes. | |
| Mirror PAH-Sch Cohort Without Selexipag | Adult patients with schistosomiasis-associated pulmonary arterial hypertension who did not receive selexipag and were followed at the same center prior to its availability. The index date (T0 mirror) is defined as the first visit at which patients met clinical eligibility criteria comparable to those of the treated cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clinical Worsening
Time from the index date (T0) to the first occurrence of clinical worsening, defined as any of the following events: all-cause mortality; lung transplantation; non-elective hospitalization due to pulmonary arterial hypertension or right heart failure; therapeutic escalation defined as initiation of parenteral prostacyclin or addition of a new class of pulmonary arterial hypertension-specific therapy; or sustained worsening of World Health Organization functional class confirmed in two consecutive assessments at least 12 weeks apart and accompanied by objective evidence of disease progression, including a ≥15% decrease in six-minute walk distance and/or a ≥30% increase in BNP or NT-proBNP compared with baseline.
Measured: From index date (T0) up to 36 months of follow-up
Secondary outcomes (10)
Clinical Improvement Composite Outcome
Composite clinical improvement defined as improvement in at least two of the following criteria compared with baseline, without occurrence of clinical worsening: increase of at least 10% or 30 meters in six-minute walk distance; improvement to World Health Organization functional class I or II; or reduction of at least 30% in BNP or NT-proBNP levels.
Measured: 6, 12, 24, and 36 months after index date
Change in WHO Functional Class
Change in WHO Functional Class
Measured: Up to 36 months of follow-up
Change in 6-Minute Walk Distance (6MWD)
Change in 6-Minute Walk Distance (6MWD)
Measured: Up to 36 months
Change in BNP or NT-proBNP Levels
Change in BNP or NT-proBNP Levels
Measured: Up to 36 months
Hemodynamic Parameters
Change in Mean Pulmonary Arterial Pressure (mPAP)
Measured: Up to 36 months of follow-up
Risk Stratification Scores
Changes in pulmonary arterial hypertension risk stratification assessed using the COMPERA 2.0 risk score (four risk strata: low, intermediate-low, intermediate-high, and high risk), evaluated during follow-up when sufficient clinical, functional, and laboratory data are available.
Measured: Up to 36 months of follow-up
Treatment Tolerability
Occurrence of adverse events during follow-up.
Measured: Up to 36 months of follow-up
Hemodynamic Parameters
Change in Pulmonary Vascular Resistance (PVR)
Measured: Up to 36 months
Hemodynamic Parameters
Change in Pulmonary Capillary Wedge Pressure (PCWP)
Measured: Up to 36 months
Hemodynamic Parameters
Change in Cardiac Output or Cardiac Index
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caio Júlio César dos Santos Fernandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caio Júlio César dos Santos Fernandes, University of Sao Paulo General Hospital
- Investigators
- Caio Fernandes, MD, Principal investigator, UNIVERSIDADE SAO PAULO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453030
- Sponsor's protocol ID
- SGP 27907
- Acronym
- PROPULSE-Sch
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. janeiro de 2019;53(1):1801913. 2. Humbert M, Sitbon O, Simonneau G. Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 30 de setembro de 2004;351(14):1425-36. 3. Calderaro D, Alves Junior JL, Fernandes CJCDS, Souza R. Pulmonary Hypertension in General Cardiology Practice. Arq Bras Cardiol [Internet]. 2019 [citado 24 de agosto de 2024]; Disponível em: https://www.scielo.br/scielo.php?pid=S0066-782X2019000900419&script=sci_arttext 4. Yoo HHB. Lesões Plexiformes na Hipertensão Arterial Pulmonar: Estamos Ficando mais Próximos do Manejo com mais Paciência e Rigor? Arq Bras Cardiol. 18 de setembro de 2020;115(3):491-2. 5. D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1o de setembro de 1991;115(5):343-9. 6. Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med. 1o de fevereiro de 1996;334(5):296-301. 7. Galiè N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 17 de novembro de 2005;353(20):2148-57. 8. Rubin LJ, Badesch DB, Barst RJ, Galiè N, Black CM, Keogh A, et al. Bosentan Therapy for Pulmonary Arterial Hypertension. N Engl J Med. 21 de março de 2002;346(12):896-903. 9. Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, et al. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 20 de abril de 2023;388(16):1478-90. 10. Mitchell JA, Ahmetaj-Shala B, Kirkby NS, Wright WR, Mackenzie LS, Reed DM, et al. Role of pr
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROPULSE-Sch: Long-Term Evaluation of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension Using a Propensity Score-Matched Mirror Cohort
- ClinicalTrials.gov ID
- NCT07453030
- Acronym / sponsor ID
- PROPULSE-Sch / SGP 27907
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- Pulmonary Arterial Hypertension, Schistosomiasis, Prostacyclin Pathway, Real-World Evidence, Propensity Score Matching, Long-Term Outcomes, Observational Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Caio Júlio César dos Santos FernandesUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 Mar 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.
Schistosomiasis-associated pulmonary arterial hypertension is a serious condition that can lead to shortness of breath, heart failure, frequent hospitalizations, and early death. Although treatments for pulmonary arterial hypertension have improved over time, patients with this specific cause of the disease are often not included in long-term studies.
Selexipag is an oral medication used to treat pulmonary arterial hypertension and is part of routine clinical care in Brazil. Its long-term effects in patients with schistosomiasis-associated pulmonary arterial hypertension are not well understood.
The PROPULSE-Sch study aims to evaluate long-term clinical outcomes in patients with schistosomiasis-associated pulmonary arterial hypertension who received selexipag, compared with similar patients who did not receive this medication before it became available at the study center.
This is an observational study using data from routine medical care. All treatments are prescribed by the treating physicians, and participation in the study does not change patient care. The results may help improve understanding of long-term outcomes and support treatment decisions in this population.
Detailed description
Schistosomiasis-associated pulmonary arterial hypertension (PAH-Sch) is a prevalent cause of pulmonary arterial hypertension in endemic regions and is associated with significant morbidity and premature mortality. Despite advances in targeted therapies for pulmonary arterial hypertension, patients with PAH-Sch remain underrepresented in long-term studies, particularly in real-world clinical settings.
Selexipag, an oral selective prostacyclin IP receptor agonist, has demonstrated clinical and hemodynamic benefits in pulmonary arterial hypertension. Following its incorporation into routine clinical practice in Brazil, selexipag has been increasingly used in eligible patients with PAH-Sch. However, evidence regarding its long-term outcomes in this specific population is limited.
PROPULSE-Sch is a single-center, observational, longitudinal study with an ambispective design, combining retrospective data and prospective follow-up. The study evaluates long-term clinical outcomes associated with exposure to selexipag in patients with PAH-Sch, compared with a mirror cohort of clinically similar patients who did not receive selexipag prior to its availability at the center. To reduce confounding and indication bias inherent to observational comparisons, analyses are conducted using propensity score matching.
All treatment decisions, including initiation and intensification of therapy, are made exclusively by the treating physicians as part of routine clinical care. The study does not mandate any intervention, treatment assignment, or protocol-driven management. Data are obtained from medical records and standard follow-up visits. By using real-world data and robust observational methods, this study aims to contribute clinically relevant evidence on long-term outcomes in schistosomiasis-associated pulmonary arterial hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selexipag-Treated PAH-Sch Cohort | – | –Adult patients with schistosomiasis-associated pulmonary arterial hypertension who initiated oral selexipag as part of routine clinical care. The index date (T0) is defined as the date of selexipag initiation recorded in the medical record. Patients are followed longitudinally to assess long-term clinical outcomes. |
| Mirror PAH-Sch Cohort Without Selexipag | – | –Adult patients with schistosomiasis-associated pulmonary arterial hypertension who did not receive selexipag and were followed at the same center prior to its availability. The index date (T0 mirror) is defined as the first visit at which patients met clinical eligibility criteria comparable to those of the treated cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients with schistosomiasis-associated pulmonary arterial hypertension (PAH-Sch) followed at a specialized pulmonary hypertension referral center. The population comprises two observational cohorts: patients who initiated oral selexipag as part of routine clinical care and a mirror cohort of clinically similar patients who did not receive selexipag prior to its availability at the center. All patients have confirmed pre-capillary pulmonary arterial hypertension and stable background therapy at the index date. Participants are followed longitudinally using data obtained from routine clinical practice to assess long-term clinical outcomes. No study-mandated interventions are performed.
Key inclusion criteria (10 listed)
- Adults aged 18 years or older.
- Confirmed diagnosis of pulmonary arterial hypertension associated with schistosomiasis (PAH-Sch).
- Diagnosis of pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization, performed at any time prior to the index date (T0), as documented in the medical record.
- Evidence of schistosomiasis infection, including epidemiological history and ultrasonographic findings compatible with hepatosplenic schistosomiasis.
- Previous antiparasitic treatment for schistosomiasis.
Key exclusion criteria (4 listed)
- World Health Organization (WHO) functional class IV at the index date.
- Progressive right heart failure or clinical deterioration within the 12 weeks prior to the index date.
- Documented formal contraindication to selexipag in the medical record.
- Insufficient baseline data at the index date to allow clinical characterization or inclusion in propensity score analyses.
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
Time to Clinical Worsening
Time frame: From index date (T0) up to 36 months of follow-up
Time from the index date (T0) to the first occurrence of clinical worsening, defined as any of the following events: all-cause mortality; lung transplantation; non-elective hospitalization due to pulmonary arterial hypertension or right heart failure; therapeutic escalation defined as initiation of parenteral prostacyclin or addition of a new class of pulmonary arterial hypertension-specific therapy; or sustained worsening of World Health Organization functional class confirmed in two consecutive assessments at least 12 weeks apart and accompanied by objective evidence of disease progression, including a ≥15% decrease in six-minute walk distance and/or a ≥30% increase in BNP or NT-proBNP compared with baseline.
10 secondary outcomes
Clinical Improvement Composite Outcome
Time frame: 6, 12, 24, and 36 months after index date
Change in WHO Functional Class
Time frame: Up to 36 months of follow-up
Change in 6-Minute Walk Distance (6MWD)
Time frame: Up to 36 months
Change in BNP or NT-proBNP Levels
Time frame: Up to 36 months
Hemodynamic Parameters
Time frame: Up to 36 months of follow-up
Risk Stratification Scores
Time frame: Up to 36 months of follow-up
Treatment Tolerability
Time frame: Up to 36 months of follow-up
Hemodynamic Parameters
Time frame: Up to 36 months
Hemodynamic Parameters
Time frame: Up to 36 months
Hemodynamic Parameters
Time frame: Up to 36 months
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 5 Mar 2026.
- Results publication1. Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. janeiro de 2019;53(1):1801913. 2. Humbert M, Sitbon O, Simonneau G. Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 30 de setembro de 2004;351(14):1425-36. 3. Calderaro D, Alves Junior JL, Fernandes CJCDS, Souza R. Pulmonary Hypertension in General Cardiology Practice. Arq Bras Cardiol [Internet]. 2019 [citado 24 de agosto de 2024]; Disponível em: https://www.scielo.br/scielo.php?pid=S0066-782X2019000900419&script=sci_arttext 4. Yoo HHB. Lesões Plexiformes na Hipertensão Arterial Pulmonar: Estamos Ficando mais Próximos do Manejo com mais Paciência e Rigor? Arq Bras Cardiol. 18 de setembro de 2020;115(3):491-2. 5. D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1o de setembro de 1991;115(5):343-9. 6. Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med. 1o de fevereiro de 1996;334(5):296-301. 7. Galiè N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 17 de novembro de 2005;353(20):2148-57. 8. Rubin LJ, Badesch DB, Barst RJ, Galiè N, Black CM, Keogh A, et al. Bosentan Therapy for Pulmonary Arterial Hypertension. N Engl J Med. 21 de março de 2002;346(12):896-903. 9. Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, et al. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 20 de abril de 2023;388(16):1478-90. 10. Mitchell JA, Ahmetaj-Shala B, Kirkby NS, Wright WR, Mackenzie LS, Reed DM, et al. Role of pr
- 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.
Caio Fernandes, MD principal investigator
UNIVERSIDADE SAO PAULO
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 Arterial Hypertension (PAH), run by Caio Júlio César dos Santos Fernandes 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 10 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Mar 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 Caio Fernandes, Principal Investigator, MD (+551126615034, cjcfernandes@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Worsening (time frame: From index date (T0) up to 36 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07453030, which also lists 1 linked publication.
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 5 Mar 2026.