What is the mechanism of action of this treatment?

Common treatments for Pulmonary Hypertension (PH) include phosphodiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists (ERAs), and prostacyclin analogs. PDE5 inhibitors increase cyclic GMP levels, leading to vasodilation and reduced pulmonary artery pressure. ERAs block endothelin-1, a potent vasoconstrictor, reducing vascular resistance. Prostacyclin analogs promote vasodilation and inhibit platelet aggregation. These treatments are crucial for PH patients as they improve pulmonary blood flow, enhance oxygenation, and improve quality of life and survival.

What side effects are associated with this type of intervention?

Common treatments for Pulmonary Hypertension, such as phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil, and prostacyclin analogs like epoprostenol, have several known side effects. PDE5Is can cause headaches, flushing, dyspepsia, and visual disturbances. Epoprostenol, administered via continuous infusion, can lead to jaw pain, diarrhea, flushing, and complications related to the central venous catheter, such as infections. These side effects are important considerations when managing PH treatment.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Pulmonary Hypertension, including prostacyclin analogs like epoprostenol, endothelin receptor antagonists such as bosentan, macitentan, and ambrisentan, and phosphodiesterase-5 inhibitors. These medications have demonstrated efficacy in improving hemodynamic parameters, functional capacity, and survival in PH patients. Imaging techniques like 129Xe MRI/MRS are being studied to monitor gas exchange and hemodynamics, providing a detailed assessment of disease progression and treatment response.

What other types of research exist?

Promising alternatives to 129Xe MRI/MRS for Pulmonary Hypertension patients include Phase-Resolved Functional Lung (PREFUL)-MRI, which evaluates pulmonary vascular disease and hemodynamics, and Oxygen-Sensitive (OS) Cardiovascular Magnetic Resonance (CMR), which assesses myocardial oxygenation and right ventricular function. Both techniques offer advanced imaging capabilities relevant to PH management.

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Gas

Xenon MRI for Pulmonary Arterial Hypertension (Jupiter PH Trial)

Phase 2

Recruiting

Led By Sudarshan Rajagopal, MD, PhD

Research Sponsored by Bastiaan Driehuys

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

WHO functional class (FC) 2-3 symptoms with a diagnosis of group 1 PH

Diagnosis of precapillary PH in the setting of Group 1 (PAH), 3 (PH due to chronic lung disease), 4 (PH due to pulmonary artery obstructions), or 5 (PH due to miscellaneous causes)

Must not have

Sickle cell anemia

Liver disease (Childs-Pugh class C)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special MRI scan with a gas to monitor lung function in patients with severe lung disease. It targets those being monitored over time to better understand and track their condition. The MRI technique provides detailed lung function measurements and is well-tolerated, allowing for thorough exploration of lung function.

Who is the study for?

This trial is for adults aged 18-75 with Pulmonary Hypertension (PH), specifically those who are newly diagnosed or have started treatment within the last three months. Participants must be able to consent and follow the study schedule, and women of childbearing age need a negative pregnancy test before MRI scans. Those awaiting lung transplants can join too, but not if they have severe liver disease, heart issues, active cancer, sickle cell anemia or conditions preventing MRI use.

What is being tested?

The trial is testing how a type of imaging called Xenon 129 Magnetic Resonance Imaging (MRI) can show changes in lung function and blood flow in patients with different types of Pulmonary Hypertension. It aims to understand how these images change with disease progression or after starting treatment.

What are the potential side effects?

Since this trial involves MRI scanning using hyperpolarized Xenon gas rather than drug interventions, typical side effects associated with medications may not apply. However, there might be risks related to lying still during the scan or reactions to inhaling Xenon gas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pulmonary hypertension symptoms are moderate.

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I have been diagnosed with a specific type of high blood pressure in my lungs.

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I am on the waiting list for a lung transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have sickle cell anemia.

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My liver condition is severe.

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I have been diagnosed with sarcoidosis.

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My pulmonary hypertension is caused by schistosomiasis.

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I have moderate to severe heart disease.

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My cancer is currently active.

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I can undergo an MRI scan without issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Red Blood Cell Signal from Xenon MRI

pulmonary vascular remodeling

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: following pulmonary arterial hypertension subjectsExperimental Treatment1 Intervention

Following pulmonary arterial hypertension subjects upto 24 months

Group II: end-stage pulmonary hypertension .Experimental Treatment1 Intervention

subjects with end-stage PH that currently on the waitlist for lung transplant

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pulmonary Hypertension (PH) include phosphodiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists (ERAs), and prostacyclin analogs. PDE5 inhibitors increase cyclic GMP levels, leading to vasodilation and reduced pulmonary artery pressure. ERAs block endothelin-1, a potent vasoconstrictor, reducing vascular resistance. Prostacyclin analogs promote vasodilation and inhibit platelet aggregation. These treatments are crucial for PH patients as they improve pulmonary blood flow, enhance oxygenation, and improve quality of life and survival.

Medications for the treatment of pulmonary arterial hypertension: a systematic review and network meta-analysis.Clinical trials in group 3 pulmonary hypertension.Pulmonary hypertension in chronic lung disease and hypoxia.