What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include phosphodiesterase-5 inhibitors (PDE5Is) such as sildenafil and tadalafil, which can cause headaches, flushing, dyspepsia, and visual disturbances. Soluble guanylate cyclase stimulators like riociguat may lead to hypotension, dizziness, and gastrointestinal symptoms. Prostacyclin analogues such as epoprostenol are associated with side effects like jaw pain, flushing, headache, nausea, and risk of bloodstream infections due to the need for continuous intravenous administration.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Pulmonary Arterial Hypertension (PAH) that aim to reduce pulmonary artery pressure and improve right heart function. Phosphodiesterase-5 inhibitors (PDE5Is) such as sildenafil and tadalafil improve pulmonary hemodynamics and exercise capacity. Soluble guanylate cyclase stimulators like riociguat have also been approved, although their primary endpoints in some trials were not significantly improved. Prostacyclin analogs, including epoprostenol and treprostinil, are used to enhance exercise capacity and hemodynamic parameters. These treatments align with the goals of the Aria CV Pulmonary Hypertension System, which is being studied for its potential to reduce pulmonary artery pressure and improve right heart function.

What other types of research exist?

Promising alternatives to the Aria CV Pulmonary Hypertension System for PAH patients include phosphodiesterase-5 inhibitors (PDE5Is) such as sildenafil, tadalafil, and vardenafil. These medications have demonstrated improvements in pulmonary hemodynamics, exercise capacity, and right heart function. Additionally, the use of durable right ventricular assist devices and ongoing research into novel mechanical support strategies also present potential treatment options.

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Device

Aria CV System for Pulmonary Arterial Hypertension (ASPIRE PH Trial)

N/A

Recruiting

Led By Aaron Waxman, M.D.,Ph.D.

Research Sponsored by Aria CV, Inc

Eligibility Criteria Checklist

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

Must have

Previous diagnosis of lung disease, including but not limited to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis, PCWP ≤ 15mmHg, PVR >4 WU (for WHO Group III)

Previous diagnosis of heart failure with preserved ejection fraction (HFpEF) (ejection fraction ≥ 50%) (for WHO Group II)

Must not have

Previous diagnosis of nonobstructive hypertrophic cardiomyopathy (for WHO Group II)

Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy - HOCM) (for WHO Group II)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post-implant

Awards & highlights

Summary

This trial is testing a new device called the Aria CV PH System, which helps manage high blood pressure in the lungs and supports heart function. It is aimed at patients with pulmonary hypertension and related heart issues. The study will check if the device is safe and effective over a period of several months to a few years.

Who is the study for?

Adults with pulmonary hypertension and right heart dysfunction who still have symptoms despite taking specific medications for at least 90 days. They must not have certain severe heart conditions, recent major cardiovascular events, or other health issues that could interfere with the trial's device.

What is being tested?

The Aria CV Pulmonary Hypertension System is being tested in this study to see if it's safe and works well for patients with pulmonary hypertension and problems with the right side of their heart.

What are the potential side effects?

Potential side effects are not explicitly listed but may include complications related to device implantation, reactions to materials in the device, or issues from required medications like blood thinners.

Eligibility Criteria

Inclusion Criteria

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

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I have a lung condition like COPD or fibrosis, but my heart and lung pressures are within specific limits.

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I have been diagnosed with heart failure but my heart still pumps well.

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I have right heart dysfunction and meet specific criteria for a heart device study.

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I am 18 years old or older.

Exclusion Criteria

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

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I have been diagnosed with a type of heart disease that thickens my heart muscle.

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I have been diagnosed with hypertrophic obstructive cardiomyopathy.

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I have been diagnosed with a severe form of pulmonary hypertension.

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I have severe untreated heart valve narrowing.

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I have been diagnosed with heart failure where my heart doesn't pump well.

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You have any of the following conditions: specific genetic mutations, history of certain heart and lung conditions, kidney problems, scleroderma with certain symptoms, specific immunosuppressant treatments, certain blood disorders, unsuitable anatomy for a medical device, specific heart valve issues, allergies to certain medications or materials, pregnancy or planning to become pregnant soon, life expectancy less than two years, participation in another research study that may affect this one, or specific oxygen therapy adherence issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post-implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post-implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-implant for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary Safety Endpoint is the incidence of investigational device- or procedure-related serious adverse events (SAEs).

Secondary study objectives

Changes in 6-Minute Walk Distance

Changes in Modified Borg Dyspnea Score (MBS)

Changes in REVEAL Score

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aria CV Pulmonary Hypertension SystemExperimental Treatment1 Intervention

Treatment with the Aria CV Pulmonary Hypertension System

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 Arterial Hypertension (PAH) include phosphodiesterase-5 inhibitors (PDE5Is), endothelin receptor antagonists (ERAs), and prostacyclin analogues. PDE5Is, such as sildenafil and tadalafil, work by increasing cyclic GMP levels, leading to vasodilation and reduced pulmonary artery pressure. ERAs, like bosentan and ambrisentan, block endothelin-1 receptors, preventing vasoconstriction and reducing vascular resistance. Prostacyclin analogues, such as epoprostenol, promote vasodilation and inhibit platelet aggregation. These mechanisms are vital for PAH patients as they help lower pulmonary artery pressure and improve right heart function, thereby enhancing exercise capacity and quality of life.

Medical Therapy Versus Balloon Angioplasty for CTEPH: A Systematic Review and Meta-Analysis.Key articles and guidelines in the management of pulmonary arterial hypertension: 2011 update.Comparative analysis of clinical trials and evidence-based treatment algorithm in pulmonary arterial hypertension.

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Who is running the clinical trial?

Aria CV, IncLead Sponsor

1 Previous Clinical Trials

18 Total Patients Enrolled

Aaron Waxman, M.D.,Ph.D.Principal InvestigatorBrigham and Women's Hospital

~0 spots leftby Oct 2024

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