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RecruitingPhase 4NCT06317805

Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients

Randomized Trial Comparing Efficacy and Safety of Initial Triple Therapy Including Parenteral Treprostinil to Initial Double Oral Therapy in Pulmonary Arterial Hypertension (PAH) Group I Patients (TripleTRE)

Sponsor

AOP Orphan Pharmaceuticals AG

Enrollment

110 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension

Summary

TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH. The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment approaches for newly diagnosed pulmonary arterial hypertension (PAH) — a serious condition where high blood pressure in the lungs strains the heart. It tests whether starting with three medications (including an injectable one) is better than starting with two oral medications. **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with PAH (specifically types including idiopathic, hereditary, drug-induced, connective tissue disease-related, or corrected congenital heart disease-related) - You have not yet started treatment for PAH - Your PAH is classified as intermediate-high risk based on standard assessments **You may NOT be eligible if...** - You have received prior treatment for PAH - You have serious other heart, liver, or kidney conditions - You are pregnant or breastfeeding - You have certain other medical conditions deemed incompatible with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGeneric treprostinil sodium + Standard of Care (Double Oral)

Treprostinil (prostacyclin analogue) solution for continuous subcutaneous (SC) or intravenous (IV) infusion (1 mg/ml; 2.5 mg/ml; 5 mg/ml; 10 mg/ml in 10 mL glass vial) will be administered by an infusion pump system and up-titrated to ≥40 ng/kg/min or to the maximum tolerated dose within 24 weeks. Further up-titration shall be performed until trial completion according to the discretion of the investigator.

DRUGStandard of Care - Double Oral

All patients will receive standard of care double oral background treatment consisting of one Phosphodiesterase type 5 inhibitor (i.e., tadalafil or sildenafil) and one Endothelin Receptor Antagonist (i.e. ambrisentan, bosentan or macitentan)

Locations(19)

Ordensklinikum Linz

Linz, Austria

Medical University Vienna

Vienna, Austria

Fakultní Nemocnice Olomouc

Olomouc, Czechia

Všeobecná fakultní nemocnice v Praze

Prague, Czechia

Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris

Paris, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

DRK Kliniken Berlin Westend

Berlin, Germany

University Hospital Carl Gustav Carus of Technical University Dresden

Dresden, Germany

Universitätsmedizin Greifswald

Greifswald, Germany

Gottsegen National Cardiovascular lnstitute

Budapest, Hungary

Medical University of Szeged

Szeged, Hungary

Sapienza University of Rome

Rome, Italy

John Paul II Hospital Krakow

Krakow, Poland

Fryderyk Chopin Hospital in European Health Centre Otwock

Otwock, Poland

Centro Hospitalar Lisboa Norte - Santa Maria University Hospital

Lisbon, Portugal

Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu

Bucharest, Romania

Emergency Clinical County Hospital of Targu Mures

Târgu Mureş, Romania

Hospital Clinic of Barcelona

Barcelona, Spain

Hospital Ramon y Cajal

Madrid, Spain

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NCT06317805

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