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Compares treatment options for Pulmonary Arterial Hypertension
Official title Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
ClinicalTrials.gov ID: NCT06317805
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Signed informed consent prior to any trial-mandated procedure
- Male or female ≥ 18 and ≤ 70 years of age
- Symptomatic treatment-naïve PAH patients (group I) with confirmed diagnosis of one of the following subgroups:
- idiopathic pulmonary arterial hypertension (IPAH)
- hereditary pulmonary arterial hypertension (HPAH)
You likely can't join if
- PAH patients (group I) belonging to one of the following subgroups:
- Schistosomiasis
- HIV infection
- Portal hypertension
- Diffuse systemic sclerosis
- Uncorrected congenital heart disease including uncorrected systemic-to-pulmonary shunts
See the full eligibility criteria
- Signed informed consent prior to any trial-mandated procedure
- Male or female ≥ 18 and ≤ 70 years of age
- Symptomatic treatment-naïve PAH patients (group I) with confirmed diagnosis of one of the following subgroups:
- idiopathic pulmonary arterial hypertension (IPAH)
- hereditary pulmonary arterial hypertension (HPAH)
- Drug and toxin-induced pulmonary arterial hypertension (DPAH)
- PAH associated with Connective Tissue Disease
- PAH with corrected congenital heart disease 4. Intermediate-high risk patients rated acc. the simplified four-strata risk-assessment tool or intermediate-low risk with severe hemodynamic impairment as defined in current...
- Right Heart Catheterization (RHC) meeting all the following criteria:
- Mean pulmonary arterial pressure (mPAP) \> 20 mmHg
- Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
- PVR \> 2 Wood Units
- Women of childbearing potential must not be pregnant or lactating, must perform regular pregnancy tests, if sexually active, agrees to continue to use reliable method(s) of contraception until study completion
- PAH patients (group I) belonging to one of the following subgroups:
- Schistosomiasis
- HIV infection
- Portal hypertension
- Diffuse systemic sclerosis
- Uncorrected congenital heart disease including uncorrected systemic-to-pulmonary shunts
- Any PAH-specific drug therapy in the past 3 months
- Patients responding to vasoreactivity testing with calcium channel blockers (CCB)
- Post-capillary PH and left heart disease
- Known or suspected pulmonary veno-occlusive disease (PVOD)
- Any PH due to lung disease
- Any disorder of the respiratory system expressed by Diffusing Capacity of Lung for Carbon Monoxide (DLCO) \<40% and a noticeable imaging result (e.g., CT) and (Total Lung Capacity) TLC \<60% and (Forced Expiratory...
- Patients with need of ambulatory or long-term oxygen therapy
- Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \> 480 msec at screening
- Body mass index (BMI) \> 35 (kg/m2)
- Age \> 70 years
- History of restrictive, constrictive or congestive cardiomyopathy, atrial septostomy, any symptomatic coronary disease events within 6 months, severe uncontrolled arterial hypertension, acutely decompensated heart...
- Patients with acute anemia with hemoglobin (Hb) values \<11g/dL
- Cerebrovascular accident within 3 months
- Documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin \> 3× upper limit of the normal range (ULN)...
- Documented renal insufficiency with Glomerular Filtration Rate (GFR) \<30 ml/min
- Patients with untreated sleep apnea
- Patient with other cardiovascular, liver, renal, hematologic, gastrointestinal (including active gastrointestinal ulcer), immunologic, endocrine (e.g., uncontrolled diabetes), metabolic, or central nervous system...
- Patients with major surgery in the last 12 months
- Known history of alcohol abuse
- Treatment of a a cytochrome P450 (CYP)2C8 enzyme inducer (e.g., rifampicin) ≤ 28 days and/or treatment of a CYP2C8 enzyme inhibitor (e.g., gemfibrozil) ≤ 28 days
- Treatment with another investigational drug (planned, or taken ≤ 12 weeks)
- Hypersensitivity to any of the trial treatments or any excipient of their formulations
- Pregnancy, breastfeeding, or intention to become pregnant during the trial
- Any other significant disease or disorder which, in the opinion of the investigator, may put the patients at risk when participating in the trial
- Any factor or condition likely to affect protocol compliance of the patient, as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Linz, Austria
- Vienna, Austria
- Olomouc, Czechia
- Prague, Czechia
- Paris, France
- Strasbourg, France
- Berlin, Germany
- Dresden, Germany
- Greifswald, Germany
- Budapest, Hungary
- Szeged, Hungary
- Rome, Italy
- Krakow, Poland
- Otwock, Poland
- Lisbon, Portugal
- Bucharest, Romania
- Târgu Mureş, Romania
- Barcelona, Spain
- Madrid, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Linz, Austria; Vienna, Austria; Olomouc, Czechia; Prague, Czechia; Paris, France; Strasbourg, France and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.