Escalation options for PAH patients already on dual therapy
Official title: 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
Run by University of Sao Paulo General Hospital · NCT07713914 · Data updated 2026-11-12
This trial tests whether adding a prostacyclin pathway drug or increasing sildenafil dose helps PAH patients at intermediate-to-high risk who aren’t at low risk despite dual therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 196 (estimated) |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | July 22, 2026 |
| Main results expected | July 1, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07713914 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with PAH on dual therapy who remain at intermediate-low, intermediate-high, or high risk and have a clinical need for escalation.
✕Probably not a fit
Patients who do not respond to escalation or who have contraindications to prostacyclin agents or sildenafil dose increases may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, open-label study enrolls adults with pulmonary arterial hypertension who remain at intermediate-low, intermediate-high, or high risk while taking an endothelin receptor antagonist plus sildenafil. Participants are assigned to either add a prostacyclin pathway agent (inhaled iloprost or selexipag) or optimize sildenafil dosing, with follow-up at 3–6 months. The primary goal is to see if the chosen escalation lowers risk category by COMPERA 2.0. Secondary endpoints include other clinical improvements and safety measures. The trial is conducted at major centers in São Paulo, Brazil, led by University of São Paulo General Hospital.
Why it matters
Potential benefit: If successful, patients could see a shift to a lower risk category and potentially better clinical outcomes.
How similar studies have gone: Earlier research supports escalation strategies in PAH, but direct randomized comparisons between these two approaches are limited, making this study relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: Caio Fernandes — Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo
- Study coordinator: Caio Fernandes, MD, PhD
- Email: cjcfernandes@yahoo.com.br
- Phone: +551126615034
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Sleep problems in PAH patients: how sleep breathing relates to PAH outcomes
This study tests how sleep-disordered breathing and nocturnal oxygen changes relate to outcomes in adults with pulmonary arterial hypertension.
-
Impact of ambient air vs nasal liquid oxygen on exercise performance in pulmonary vascular disease
This study tests whether using nasal liquid oxygen during a 6-minute walk test changes how far patients with PAH or CTEPH can walk compared to breathing room air.
-
Liquid oxygen vs ambient air during a 6-minute walk in people with pulmonary vascular disease
This study tests whether walking with liquid oxygen at about 4 L/min helps or hinders distance walked compared with walking on room air in adults with PAH or CTEPH living in Switzerland.
-
Treprostinil inhalation powder for PAH patients switching from selexipag
This study tests whether inhaled treprostinil (LIQ861) is safe and tolerable for adults with PAH who are moving from oral selexipag to inhaled therapy.
-
Vasoactive Agents in Pulmonary Hypertension Crisis
This trial tests whether dopamine, norepinephrine, or epinephrine can safely and effectively help people with a pulmonary hypertension crisis who are in the hospital.
-
Tele-Pulmonary Rehabilitation for Chronic Lung Diseases
This study tests whether a remote tele-rehabilitation program helps people with chronic lung diseases start and stick with pulmonary rehab better than usual center-based care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.