NCT07713914 Randomized Study of Triple Therapy vs Sildenafil Dose Optimization in Pulmonary Arterial Hypertension
| NCT ID | NCT07713914 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Pulmonary Arterial Hypertension (PAH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2026-07-22 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 196 participants in total. It began in 2026-07-22 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pulmonary arterial hypertension (PAH) is a rare and progressive disease characterized by increased pressure in the pulmonary arteries, leading to right heart failure and premature death. Although combination therapy has improved outcomes, many patients remain at intermediate or high clinical risk despite treatment. When patients do not reach low-risk status, treatment escalation is recommended. However, different escalation strategies are used in clinical practice, including increasing the dose of existing medications or adding a third drug that targets a different biological pathway. There is limited prospective randomized evidence directly comparing these approaches. The ASCEND-PAH study is a prospective, randomized, open-label clinical trial designed to compare two therapeutic escalation strategies in adults with PAH who remain at intermediate or high risk despite dual therapy with an endothelin receptor antagonist and sildenafil. Participants will be randomized to either: (1) escalation to triple therapy with the addition of a prostacyclin pathway agent, or (2) optimization of dual therapy by increasing the dose of sildenafil. The primary objective is to compare the proportion of patients who improve their risk category according to the COMPERA 2.0 four-stratum risk model within 3 to 6 months after randomization. Secondary outcomes include changes in functional status, exercise capacity, biomarkers, clinical worsening, safety, and treatment persistence
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Diagnosis of pulmonary arterial hypertension (PAH, Group 1) confirmed according to accepted clinical and hemodynamic criteria * Stable treatment with an endothelin receptor antagonist in combination with sildenafil prior to randomization * Classified as intermediate-low, intermediate-high, or high risk according to the COMPERA 2.0 four-stratum model * Clinical indication for therapeutic escalation * Availability for follow-up assessment between 3 and 6 months after randomization * Ability to provide written informed consent Exclusion Criteria: * Participation in another interventional clinical trial that mandates treatment modification * Known contraindication to prostacyclin pathway agents (including iloprost or selexipag) * Known contraindication to sildenafil dose escalation * Pregnancy or breastfeeding * Women of childbearing potential not using effective contraception * Any clinical condition that, in the investigator's judgment, would interfere with study participation or outcome assessment
Contact & Investigator
Caio Fernandes
PRINCIPAL INVESTIGATOR
Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo
Frequently Asked Questions
Who can join the NCT07713914 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Arterial Hypertension (PAH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07713914 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07713914 currently recruiting?
Yes, NCT07713914 is actively recruiting participants. Contact the research team at cjcfernandes@yahoo.com.br for enrollment information.
Where is the NCT07713914 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07713914 clinical trial?
NCT07713914 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Caio Fernandes at Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo. The trial plans to enroll 196 participants.