What is the mechanism of action of this treatment?

Common treatments for heart failure include ACE inhibitors, beta-blockers, diuretics, and cardiac resynchronization therapy (CRT). ACE inhibitors reduce blood pressure and decrease the workload on the heart by inhibiting the conversion of angiotensin I to angiotensin II. Beta-blockers slow the heart rate and reduce blood pressure by blocking the effects of adrenaline. Diuretics help remove excess fluid from the body, reducing the strain on the heart. CRT improves the timing of the heart's contractions by coordinating the action of the left and right ventricles. Pulmonary artery denervation, similar to these treatments, aims to reduce pulmonary artery pressure by disrupting sympathetic nerve activity. This is crucial for heart failure patients as it can alleviate symptoms, improve quality of life, and potentially reduce hospitalizations by addressing the underlying hemodynamic abnormalities.

What side effects are associated with this type of intervention?

Common treatments for heart failure include inotropes, vasopressors, and pulmonary vasodilators. Inotropes can cause arrhythmias and increased myocardial oxygen consumption. Vasopressors may lead to hypertension, ischemia, and arrhythmias. Pulmonary vasodilators, such as inhaled nitric oxide, can improve oxygenation but may cause renal impairment and have not shown a reduction in morbidity or mortality. Pulmonary artery denervation, a newer treatment under study, aims to reduce pulmonary artery pressure by disrupting sympathetic nerve activity, but its long-term side effects are still being evaluated.

What prior FDA approvals exist?

FDA-approved treatments for heart failure include a variety of pharmacologic agents and device-based therapies. Pharmacologic treatments such as ACE inhibitors, angiotensin receptor blockers, beta-blockers, and diuretics are commonly used to manage heart failure symptoms and improve outcomes. Additionally, cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs) are device-based therapies that have been approved to improve heart function and reduce mortality in heart failure patients. While pulmonary artery denervation is still under investigation, other treatments targeting pulmonary hypertension, such as PDE-5 inhibitors (e.g., sildenafil) and endothelin receptor antagonists (e.g., bosentan), have been explored, though with mixed results in heart failure patients.

What other types of research exist?

Promising novel alternatives to Pulmonary Artery Denervation for heart failure patients with pulmonary hypertension include: 1) Oral sildenafil citrate, which has shown efficacy in pediatric pulmonary arterial hypertension and is being explored in adults. 2) Continuous positive airway pressure (CPAP) therapy, which improves pulmonary hemodynamics in patients with obstructive sleep apnea. 3) Prostacyclin analogs and endothelin receptor antagonists, which are established treatments but continue to evolve with new formulations and delivery methods. 4) Renal sympathetic denervation, which has shown potential in preventing the development of pulmonary arterial hypertension and cardiac dysfunction in preclinical studies.

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Procedure

Denervation System for Heart Failure and Pulmonary Hypertension (PreVail-PH2 Trial)

N/A

Recruiting

Research Sponsored by Gradient Denervation Technologies

Eligibility Criteria Checklist

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

Must have

NYHA Class II or III

Be older than 18 years old

Must not have

Severe aortic, mitral or pulmonary valve regurgitation

Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 1- and 6- months post-procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new procedure called PADN that reduces nerve activity in lung arteries. It aims to help heart failure patients with pulmonary hypertension, who currently have no other treatments. By calming these nerves, it may lower lung blood pressure and improve heart function. Pulmonary artery denervation (PADN) has been clinically shown to be effective in controlling pulmonary hypertension.

Who is the study for?

This trial is for heart failure patients with a specific type of high blood pressure in the lungs (Group 2 Pulmonary Hypertension). Participants must have a certain level of heart function, kidney function, and meet other specific health measures. They should be experiencing moderate symptoms but on stable treatment.

What is being tested?

The study is testing the Gradient Denervation System to see if it improves quality of life for these patients. It's an early-stage study focusing on how this procedure affects people with both heart failure and pulmonary hypertension.

What are the potential side effects?

As this is an early feasibility study, detailed side effects are not provided. However, procedures like denervation could potentially cause complications such as bleeding, infection or damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

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

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I have moderate heart condition symptoms.

Exclusion Criteria

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

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I have severe leakage in my heart valves.

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I cannot take certain blood thinners due to allergies or other reasons.

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I don't have major issues with my pulmonary artery that would prevent safe treatment.

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I have a leaky heart valve and liver issues due to cirrhosis or heart-related liver problems.

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I do not have blood clots in the areas to be treated in my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 1- and 6- months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 1- and 6- months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 1- and 6- months post-procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Device and procedure related serious adverse events

Secondary study objectives

Change in PVR

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: PADN with Gradient Denervation SystemExperimental Treatment1 Intervention

Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

0 / 6Eligibility 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 heart failure include ACE inhibitors, beta-blockers, diuretics, and cardiac resynchronization therapy (CRT). ACE inhibitors reduce blood pressure and decrease the workload on the heart by inhibiting the conversion of angiotensin I to angiotensin II. Beta-blockers slow the heart rate and reduce blood pressure by blocking the effects of adrenaline. Diuretics help remove excess fluid from the body, reducing the strain on the heart. CRT improves the timing of the heart's contractions by coordinating the action of the left and right ventricles. Pulmonary artery denervation, similar to these treatments, aims to reduce pulmonary artery pressure by disrupting sympathetic nerve activity. This is crucial for heart failure patients as it can alleviate symptoms, improve quality of life, and potentially reduce hospitalizations by addressing the underlying hemodynamic abnormalities.

Cardiac and pulmonary arterial remodeling after sinoaortic denervation in normotensive rats.