NCT07713914RecruitingPhase 4
Randomized Study of Triple Therapy vs Sildenafil Dose Optimization in Pulmonary Arterial Hypertension
A Prospective, Randomized, Open-Label Study Comparing Triple Therapy Versus Sildenafil Dose Optimization in Patients With Pulmonary Arterial Hypertension Using COMPERA 2.0 Risk Stratification as the Primary Outcome
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- First submitted
- 14 Jul 2026
- Start date
- 22 Jul 2026
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- University of Sao Paulo General Hospital
- NCT number
- NCT07713914
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 196
- From 22 Jul 2026 to the primary completion date, 1 Jul 2028
- 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
- Any clinical condition that, in the investigator's judgment, would interfere with study participation or outcome assessment
Other
- 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
Who the study is looking for
- 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
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 |
|---|---|---|---|
| Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.