Surgical Resection of the Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction

NCT03715543 | Completed

• 1 other identifier: GSN FIH Study
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 2

Brief Summary

We believe that blocking of the Greater Splanchnic Nerve (GSN) will stop Sympathetic Nervous System (SNS) activity from reaching the splanchnic vessels and result in a redistribution of blood volume back into the splanchnic reservoir, which will result in reduction of central venous, pulmonary and right and left heart pressures. For patients having Heart Failure With Preserved Ejection Fraction (HFpEF) we expect these changes to improve dyspnea and capacity to exercise, improve quality of life, increased diuretic responsiveness, Furthermore, the expected benefits of unloading the central venous and arterial system through GSN ablation should improve hemodynamic control and lessen the incidence and severity of acute decompensations leading to reduced re-hospitalizations and associated healthcare costs. This has the potential for significant social and healthcare impact.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Blunting or delay in rise of Pulmonary Capillary Wedge Pressure (PWCP) or Pulmonary Artery Diastolic Pressure (PAD) during exercise

  at 1 month post-procedure as compared to baseline

Secondary Outcomes (1)

• Reduction in resting Pulmonary Capillary Wedge Pressure (PWCP) or Pulmonary Artery Diastolic Pressure (PAD)

  at 1 and 3 months post-procedure

Study Arms (1)

Surgical Resection Arm

EXPERIMENTAL

Surgical Resection of the Greater Splanchnic Nerve

Procedure: Surgical Resection of the Greater Splanchnic Nerve

Interventions

Surgical Resection of the Greater Splanchnic Nerve PROCEDURE

Video-Assisted Thoracoscopic Surgery (VATS) is performed under general anesthesia using existing, CE marked instrumentation. Two or more 5 mm incisions are used to pass a tiny video camera and a single dissecting instrument into the chest. These small ports are advantageous because the chance for infection and wound dehiscence are drastically reduced. This allows for a faster recovery by the patient and a greater chance for the wound to heal. In the procedure the GSN will be identified visually or through stimulation-induced hemodynamic reflex. The GSN will then be ablated using standard techniques. If there are multiple branches of the GSN, each branch will be systematically identified and ablated.

Surgical Resection Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ≥ 18 years of age with guideline defined HFpEF class III/IV (EF\>40% on optimal medical therapy)
• History of exertion-related dyspnea in last 3 months
• No evidence of clinically significant peripheral edema/fluid overload
• Resting PCWP or PAD \> 15 mmHg or \> 25 mmHg during exercise
• The ability understand and provide signed informed consent

You may not qualify if:

• Myocardial infarction and/or percutaneous cardiac intervention within past 3 months; coronary artery bypass graft in past 3 months or current indication for coronary revascularization
• Admission for HF within the past month
• Systolic Blood Pressure (BP) \< 120 mmHg or \> 170 mmHg despite appropriate medical management
• Inability to perform Cardio Pulmonary Exercise Test (CPET)
• Presence of severe regurgitant or stenotic valve disease
• Atrial fibrillation with resting heart rate \>100 beats/min
• Arterial oxygen saturation \< 90 % on room air
• Significant hepatic impairment, defined as 3× upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
• Known pre-existing severe pulmonary hypertension
• Chronic pulmonary disease requiring home O2, hospitalization for exacerbation within 6 months before study entry, or on chronic steroids
• Life expectancy \<12 months for non-cardiovascular reasons
• Women of childbearing age
• Currently requiring dialysis or estimated glomerular filtration rate \< 40 mL/min/1.73m2
• Patients who have had cardiac transplantation or maybe considered for heart transplant
• Currently participating in an investigational drug or device study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered to be investigational trials

Sponsors & Collaborators

• Noblewell: lead
• Coridea: collaborator
• Axon Therapies: collaborator

Study Sites (2)

Na Homolce Hospital

Prague, 150 30, Czechia

Location

4th Military Hospital with Polyclinic

Wroclaw, 50-981, Poland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: October 23, 2018
• Study Start: August 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

CZ (1); PL (1)