Health TrialsbyHealthPanel

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF

ConditionHeart Failure With Preserved Ejection Fraction (HFpEF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorAxon Therapies, Inc.

About this trial

The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve. The study includes people who have heart failure with preserved ejection fraction (HFpEF). The goal is to learn whether this procedure, performed using the Satera Ablation System, may help improve symptoms and to better understand which patients may benefit most from this treatment in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Symptoms of HF requiring current (intermittent or continuous) treatment with diuretics for >30 days, AND

NYHA class II with a history of >NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening or signs of HF (any rales post cough, chest x-ray demonstrating pulmonary congestion), AND

Ongoing stable GDMT HF management (unless unable to tolerate GDMT) and management of potential comorbidities according to the 2022 ACCF/AHA Guideline for the Management of Heart Failure (Class 1 and 2a recommendations), with no significant changes [≥100% increase or ≥50% decrease] for a minimum of 1 month (30 days) prior to screening, that is expected to be maintained without change for at least 6 months. Participants cannot have started a glucagon-like peptide (GLP)-1 or gastric inhibitory peptide (GIP) agonist within the last 6 months or plan to start a GLP-1 or GIP agonist within the ensuing 6 months after enrollment.

LVEF ≥50% (site-determined by transthoracic echocardiography) within the past 6 months.

Disqualifiers

MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization.

Cardiac resynchronization therapy initiated within 3 months prior to screening.

ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.

Inotropic infusion (continuous or intermittent) within 6 months prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Greater Splanchnic Nerve Ablation

    Device

    The greater splanchnic nerve (GSN) ablation procedure begins with a small needle puncture in the groin or neck to access a vein, using methods that are commonly used for heart procedures. Doctors then guide thin tubes and wires through the vein to reach a nerve called the right greater splanchnic nerve. X-ray imaging is used to help the doctor see where the catheter is and guide it to the correct location. Once the catheter is in the right place, the doctor uses the device to treat the nerve using controlled heat.

  • Sham Control

    Device

    During the sham procedure, a small needle puncture will be made in the groin or neck to access a vein using standard medical techniques. A short tube will be placed into the vein, similar to what is done for many heart procedures. The Satera catheter and treatment devices will not be inserted, and the nerve will not be treated. The procedure will take about the same amount of time as the treatment procedure.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Greater Splanchnic Nerve AblationActive comparator 1 intervention
Group B: Sham Control ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary Safety Endpoint: Device or procedure related serious adverse events

Evaluation of device or procedure-related serious adverse events at 1-month follow-up based on Clinical Events Committee (CEC) assessment

Time frame
1 Month
2

Primary Efficacy Endpoint: KCCQ (6 months)

Assessment of change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6-month follow up visit

Time frame
Baseline through 6-months
3

Primary Efficacy Endpoint: 6MWT (6 months)

Assessment of change in Six Minute Walk Test (6MWT) from baseline to the 6-month follow up visit

Time frame
Baseline through 6 months

Secondary outcomes

1

Pulmonary Capillary Wedge Pressure (PCWP)

Change in pulmonary capillary wedge pressure (PCWP) at resting, legs up, 20 Watts, and Peak Exercise Stage from Baseline to the 1-month follow up visit

Time frame
Baseline through 1-month
2

Stress blood volume

Change in estimated stress blood volume at resting, legs up, 20Watts, and Peak Exercise Stage from Baseline to the 1-month follow up visit.

Time frame
Baseline through 1-month
3

NT-proBNP

Change in NT-proBNP levels from Baseline through the 24-month visit

Time frame
Baseline through 24-months
4

KCCQ (24-months)

Change in KCCQ scores from baseline through the 24-month visit

Time frame
Baseline through 24-months

Other outcomes

1

Exploratory endpoint: Heart failure related medication changes (24-months)

Freedom from heart failure related medication changes through the 24-month visit

Time frame
Baseline through 24-months
2

Exploratory Endpoint: Diuretic medication (24-months)

Change in diuretic dose through the 24-month visit

Time frame
Baseline through 24-months
3

Exploratory Endpoint: Diastolic function (24-months)

Assessment of diastolic function by transthoracic echocardiography evaluated over time from baseline through 24-months

Time frame
Baseline through 24-months
4

Exploratory Endpoint: C-reactive protein

Change in c-reactive protein levels from Baseline through 24-months

Time frame
Baseline through 24-months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Axon Therapies, Inc.

Lead sponsor

NAMSA

Collaborator

Cardiovascular Research Foundation, New York

Collaborator

Northwestern University

Collaborator

Source ClinicalTrials.gov
Apply now