COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
Pulmonary arterial hypertension (PAH) is a rare, progressive disease associated with poor prognosis, especially in patients with cardiovascular comorbidities. Current guidelines recommend initial combination therapy, but evidence is lacking for patients with significant comorbidities who are often excluded from clinical trials.
The COMMODITIES trial is a multicenter, randomized, controlled study designed to compare the efficacy and safety of initial dual oral combination therapy (tadalafil and ambrisentan) versus oral monotherapy in newly diagnosed PAH patients with at least two cardiovascular comorbidities. The study aims to provide robust evidence to guide treatment strategies in this high-risk population.
Eligibility criteria
Qualifiers
Initial PAH diagnosis < 6 months preceding randomisation
Negative vasoreactivity test
Treatment-naïve PAH (group 1): idiopathic, heritable, associated with drugs and toxin, associated with connective tissue disease, HIV infection or systemic-to-pulmonary congenital shunt corrected for more than one year
mPAP≥25 mmHg and
Disqualifiers
Porto-pulmonary hypertension
Uncorrected systemic-to-pulmonary congenital shunt
Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scan or CT pulmonary angiography
Patients listed for lung or heart-lung transplantation at time of screening
Trial design
Treatments tested in this trial
- Tadalafil
- Ambrisentan
- Placebo (Ambrisentan-matching)
Treatment groups
186 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov