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COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities

ConditionsPulmonary Arterial Hypertension (PAH)ComorbiditiesCardiovascular Disease (CVD)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tadalafil

    Drug

    Oral phosphodiesterase-5 inhibitor. Initiated at 20 mg once daily for 7 days, then increased to 40 mg once daily (2 × 20 mg tablets). Dose may be reduced to 20 mg once daily if not tolerated.

  • Ambrisentan

    Drug

    Oral endothelin receptor antagonist. Initiated at 5 mg once daily for 4 weeks, then increased to 10 mg once daily (2 × 5 mg tablets). Dose may be maintained at 5 mg once daily in case of intolerance.

  • Placebo (Ambrisentan-matching)

    Drug

    Matching placebo for ambrisentan, 2 tablets once daily, identical in appearance to active drug.

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: Tadalafil + AmbrisentanExperimental treatment 2 interventions
Group B: Tadalafil + PlaceboActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mesurement of the risk profile according to the non-invasive 4-risk strata method

Proportion of patients with PAH and with at least two cardiovascular comorbidities who achieve after 24 week a low- or an intermediate-low risk profile according to the non-invasive 4-risk strata method as proposed by the 2022 european pulmonary hypertension guidelines.

Time frame
Week 24

Secondary outcomes

1

Pulmonary vascular resistance

Change from baseline to Week 24 in pulmonary vascular resistance, assessed by right heart catheterization and expressed in Wood units (WU).

Time frame
week 24
2

BNP or NT-proBNP

Percent change from baseline to week 24 in BNP or NT-proBNP

Time frame
Week 24
3

6-Minute Walk Distance (6-MWD)

Change from baseline to week 24 in 6-MWD

Time frame
Week 24
4

WHO/NYHA Functional class

Proportion of participants who improve in WHO/NYHA FC at the end of the DBPC Treatment period

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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