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Heart Failure With Preserved Ejection Fraction (HFpEFRebalance-HFNCT04592445

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

A study testing Greater Splanchnic Nerve Ablation in people with Heart Failure With Preserved Ejection Fraction (HFpEF, run by Axon Therapies, Inc. at 26 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Greater Splanchnic Nerve Ablation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
26 sitesin 2 countries
Study dates
18 Dec 2020to 10 Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic heart failure, defined as:
  • 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
  • At least one of the following:
  • ≥1 HF hospital admission (with HF as the primary diagnosis) including treatment with intravenous (IV) diuretics or urgent unplanned treatment with IV diuretics in healthcare facility within past 12 months, OR ii. NT-proBNP >300 pg/ml in normal sinus rhythm (>450 pg/ml in atrial fibrillation or flutter) within the past 6 months; BNP >100 pg/ml in normal sinus rhythm (>300 pg/ml in atrial fibrillation or flutter) within the past 6 months, OR iii. Right heart catheterization (RHC) with PCWP ≥ with PCWP ≥18 mmHg at rest or 25 mmHg during exercise at the time of the screening RHC.
  • 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.
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  • LVEF ≥50% (site-determined by transthoracic echocardiography) within the past 6 months.
  • Age ≥40 years.
  • Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.

Who cannot join

  • 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.
  • Advanced heart failure defined as one or more of the following:
  • ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.
  • Inotropic infusion (continuous or intermittent) within 6 months prior to screening.
  • Subject is on the cardiac transplant waiting list.
Show all 39Show fewer
  • Presence of or prior history of mechanical circulatory support for HF.
  • Poor left heart compliance as determined by pulse-wave Doppler transmitral early-to-late (E/A) ratio >2.0 assessed by the screening echocardiogram. The Screening Committee will evaluate left heart function if the transmitral A velocity is not measurable or absent.
  • Right heart dysfunction defined as tricuspid annular plane systolic excursion (TAPSE) <12 mm or right ventricular (RV) fractional area change (FAC) <25% assessed by the screening echocardiogram.
  • Body mass index (BMI) >45 kg/m2.
  • 6-minute walk test distance <100 meters OR >450 meters.
  • Admission for HF within the 30 days prior to planned index procedure.
  • Any known history of orthostatic hypotension or orthostatic hypotension at the time of screening (regardless of the presence of symptoms). Orthostatic hypotension is defined as a systolic blood pressure (BP) decrease of >20 mmHg upon going from supine to standing position or undergoing treatment with Midodrine.
  • Orthostatic pulse pressure change from supine to standing decrease of >10mmHg in the absence of a HR increase >15bpm
  • Postural orthostatic tachycardia syndrome or preload insufficiency syndrome.
  • Systolic BP <100 mmHg or >170 mmHg despite appropriate medical management.
  • Baseline screening ECG resting HR >100 beats per minute or ventricular tachycardia.
  • Catheter ablation for atrial fibrillation within 6 months prior to screening or planned in the next 12 months at the time of screening.
  • Left ventricular EF <40% within the 3 years prior to screening unless reduced EF was transient and associated with an acute event.
  • Presence of significant valve disease defined by the site cardiologist as:
  • Greater than mild mitral valve stenosis.
  • Greater than moderate mitral valve regurgitation.
  • Greater than moderate-to-severe tricuspid valve regurgitation.
  • Greater than moderate aortic valve stenosis or regurgitation.
  • Known hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).
  • History of clinically significant liver cirrhosis.
  • Prior weight loss surgery
  • Dialysis dependent; or estimated GFR <25 ml/min/1.73 m2 by CKD-EPI creatinine equation.
  • Arterial oxygen saturation <90% on room air.
  • Chronic pulmonary disease requiring continuous home oxygen OR hospitalization for exacerbation of chronic pulmonary disease (including intubation) in the 12 months before study entry OR known history of GOLD Class III or worse chronic obstructive pulmonary disease (COPD).
  • Participating in conflicting investigational drug or device study that is not completed within 30 days prior to the screening visit.
  • Life expectancy <12 months for non-cardiovascular reasons.
  • Any condition, or history of illness or surgery that, in the opinion of the site investigator or Screening Committee, might confound the results of the study or pose additional risks to the patient.
  • Females who are pregnant or lactating or planning to become pregnant during the next year.
  • Any of the following measured by screening right heart catheterization:
  • Mean right atrial pressure (RAP) >20 mmHg at rest
  • Cardiac index <2.0 L/min/m2 at rest
  • Pulmonary vascular resistance (PVR) >4 Wood units
  • Vessel tortuosity or variant vascular anatomy that could preclude the access or maneuvering of the interventional device from the access site to target vessel. This includes previous spine surgery that may impact the ability to access and treat the target sites of T11 and T10.

Trial locations and contacts

26 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Judit Adorjan contact

16507221119

j.adorjan@axontherapies.com

Desiree McFee, MS contact

6123568881

desiree@axontherapies.com

26 sites in 2 countries

United States24 sites, 18 recruiting

  • Michigan Medicine, University of Michigan

    Ann Arbor, Michigan, 48109

    Nikita Sawant Dessai, dessai@med.umich.edu

    Scott Hummel, MD

    Recruiting

  • Piedmont

    Augusta, Georgia, 30901

    Jennifer Hansen, RN, 706-724-2463, Jennifer.Hansen@piedmont.org

    Kimberly Allen, RN, 706-945-6961, kimberly.allen3@piedmont.org

    Not yet recruiting

  • Cardiology PC

    Birmingham, Alabama, 35211

    Completed

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Elly Borhanian, borhania@musc.edu

    Sheldon Litwin, MD

    Recruiting

  • Bluhm Cardiovascular Institute of Northwestern University

    Chicago, Illinois, 60611

    Daniel Roshevsky, droshevs@nm.org

    Ravi Patel, MD

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Adaeze Emeka, adaeze.emeka@bsd.uchicago.edu

    Nai Qashou, nai.qashou@bsd.uchicago.edu

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Shelby Johnson, 513-585-4849, Shelby.Johnson@thechristhospital.com

    Odayme Quesada, MD

    Not yet recruiting

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Halle Woodruff, halle.woodruff@osumc.edu

    Alexandria Miller, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Matthew Gray, james.gray@duke.edu

    Marat Fudim, MD, MHS

    Recruiting

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

    Kimberly Lirette, kimberly.lirette@cardio.com

    Peter Fail, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Claudell Montano, 713-798-6832, claudell.montano@bcm.edu

    Ajith Nair, MD

    Recruiting

  • Ascension St. Vincent - Cardiovascular Research Institute

    Indianapolis, Indiana, 46260

    Completed

  • Scripps Health

    La Jolla, California, 92037

    Stefania Marzano, marzano.stefania@scrippshealth.org

    Rajeev Mohan, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10021

    Sara Kirschner, ski4008@med.cornell.edu

    Parag Goyal, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Completed

  • Columbia University Medical Center

    New York, New York, 10032

    Benita Cui, bc3329@cumc.columbia.edu

    Nir Uriel, MD

    Recruiting

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

    Completed

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

    Completed

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Annabelle Fuemffinger, 507-422-3801, Fuenffinger.Annabelle@mayo.edu

    Barry Borlaug, MD

    Recruiting

  • Rochester General Hospital

    Rochester, New York, 14621

    Kathleen Ebeling, RN, kathleen.ebeling@rochesterregional.org

    Vishal Parikh, DO

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Priscilla Zhang, 415-514-7903, Priscilla.Zhang@ucsf.edu

    Liviu Klein, MD

    Recruiting

  • Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California, 94143

    Kathrine (Kati) Steineman, 707-718-3130, katherine.steineman@ucsf.edu

    Lucas ZIer, MD

    Recruiting

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701

    Completed

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

    Melissa McCann, mmccann@slhv.com

    Gil Vardi, MD

    Recruiting

Other trials in United States

Georgia2 sites, 1 recruiting

  • Tbilisi Heart and Vascular Center

    Tbilisi

    Teona Zirakashvili, zirakashvilit@gmail.com

    Tamaz Shaburishvili, MD

    Recruiting

  • Tbilisi Heart Center

    Tbilisi

    Active, not recruiting

Other trials in Georgia

About this study

Official title: Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction: Randomized Controlled Feasibility Trial - The Rebalance HF Study

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.

Read the detailed description

Up to 150 people will take part in this clinical study.

Phase I of the REBALANCE-HF Study

The first part of the study took place between January 2021 and March 2023. During this phase, 116 patients participated. Researchers reviewed the results to learn whether the procedure appeared safe and whether it might help improve symptoms in people with heart failure with preserved ejection fraction (HFpEF).

This early review showed encouraging results in some patients. It also helped researchers identify a group of patients who seemed more likely to benefit from the procedure.

Phase II of the REBALANCE-HF Study:

The current phase of the study focuses on patients who have similar characteristics to those who responded well in Phase I. The goal is to confirm whether this group of patients may benefit most from the treatment and whether the procedure should be studied further in a larger future trial.

This study will take place at multiple hospitals and research centers.

Participants who qualify for the study will be randomly assigned to one of two groups:

  • Treatment group: The procedure is performed using the Satera Ablation System to treat a nerve called the greater splanchnic nerve.
  • Control (sham) group: A simulated procedure is performed, but the treatment itself is not delivered.

Participants will be assigned to a group by chance, similar to flipping a coin, although twice as many patients will receive the treatment as the sham procedure (2:1 ratio).

The group assignment will happen during the procedure after anesthesia is given, and only after the doctor confirms that the patient's anatomy is suitable for the procedure.

Blinding:

To make sure the results are fair and unbiased:

  • Participants and their heart failure doctors will not know whether the patient received the treatment or the sham procedure.
  • The doctor performing the procedure and certain study staff will know which procedure is performed so they can carry out the procedure safely.
  • The study safety team will also know this information to help monitor patient safety.

Sham Procedure:

A sham procedure is used to help researchers understand whether any improvements are due to the treatment itself or to the placebo effect.

During the sham procedure:

A small needle puncture is made in the groin or neck, similar to what is done for many heart procedures.

Doctors check the veins to confirm whether the procedure could have been performed.

However, the treatment catheter is not used and the nerve is not treated.

The sham procedure takes about 45 minutes, which is about the same amount of time as the treatment procedure.

Number of Participants:

90 patients were assigned to treatment or sham during Phase I.

In Phase II, up to 60 additional patients will be enrolled.

About 40 patients will receive the treatment, and about 20 will receive the sham procedure.

Being tested
Greater Splanchnic Nerve Ablation, Sham Control
Keywords
Heart Failure with Preserved Ejection Fraction (HFpEF), HFpEF, Greater Splanchnic Nerve, GSN

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Greater Splanchnic Nerve AblationDevice

    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 ControlDevice

    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.

Study groups in NCT04592445
Study groupRoleWhat they receive
Greater Splanchnic Nerve AblationActive comparatorAfter anesthesia is given, doctors will use the Satera Ablation System to reach a nerve called the right greater splanchnic nerve. Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve.
Receives: Device: Greater Splanchnic Nerve Ablation
Sham Control ArmSham comparatorAfter anesthesia is given, doctors will place a small tube into a vein. The steps and length of the procedure will be similar to the Axon treatment procedure, but the study treatment will not be performed.
Receives: Device: Sham Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: Baseline through 6 months

Secondary outcomes (15)

  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

    Measured: 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.

    Measured: Baseline through 1-month

  3. NT-proBNP

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

    Measured: Baseline through 24-months

  4. KCCQ (24-months)

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

    Measured: Baseline through 24-months

  5. 6MWT (24-months)

    Change in 6MWT from Baseline through the 24-month visit

    Measured: Baseline through 24-months

  6. Time to first heart failure event

    Time to first heart failure event (hospitalizations and worsening heart failure events) through the 24-month visit

    Measured: Treatment through 24-months

  7. Incidence of heart failure events

    Incidence of heart failure events (hospitalizations and worsening heart failure events) through the 24-month visit

    Measured: Treatment through 24-months

  8. Hierarchical composite endpoint (12-months)

    Composite endpoint of cardiovascular death, heart failure events, and changes in KCCQ from Baseline to the 12-month visit

    Measured: Baseline through 12-months

  9. Incidence of serious device related cardiac or vascular events

    Assessment of the incidence of serious device related cardiac or vascular events through 12- and 24-months

    Measured: Treatment through 12- and 24-months

  10. Device or procedure related pain

    Assessment of device or procedure related pain lasting at least 30 days and requiring medical management

    Measured: Treatment through 24-months

  11. Orthostatic hypotension

    Incidence of new orthostatic hypotension up to 12- and 24-months

    Measured: Treatment through 12- and 24-months

  12. Acute Kidney Injury (AKI)

    Incidence of AKI requiring renal replacement therapy up to 12- and 24-months

    Measured: Baseline through 12-and 24-months

  13. Glomerular Filtration Rate (GFR)

    Incidence of worsening GFR (defined as >50% for at least 30 days in duration) up to 12- and 24-months

    Measured: Baseline through 12- and 24-months

  14. Adverse Events

    Incidence of all Adverse Events through 12- and 24-months

    Measured: Procedure through 12- and 24-months

  15. Mortality

    Incidence of all mortality for up to 6-, 12-, and 24-months summarized as all-cause mortality, CV mortality, or heart failure-related

    Measured: Procedure through 6-, 12- and 24-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start18 Dec 2020
  3. Primary completion10 Jan 2028 (estimated)
  4. Study completion10 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase I: Subjects randomized 1:1 (treatment to sham control); cross-over offered Phase II: Subjects randomized 2:1 (treatment to sham control): cross-over offered
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04592445
Sponsor's protocol ID
09868
Acronym
Rebalance-HF
Status last verified
Sep 2026
First submitted
7 Oct 2020
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Ziaeian B, Fonarow GC. Epidemiology and aetiology of heart failure. Nat Rev Cardiol. 2016 Jun;13(6):368-78. doi: 10.1038/nrcardio.2016.25. Epub 2016 Mar 3.

    PubMed 26935038

  • Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.

    PubMed 29386200

  • Gheorghiade M, Vaduganathan M, Fonarow GC, Bonow RO. Rehospitalization for heart failure: problems and perspectives. J Am Coll Cardiol. 2013 Jan 29;61(4):391-403. doi: 10.1016/j.jacc.2012.09.038. Epub 2012 Dec 5.

    PubMed 23219302

  • Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

    PubMed 35363499

  • Lam CS, Donal E, Kraigher-Krainer E, Vasan RS. Epidemiology and clinical course of heart failure with preserved ejection fraction. Eur J Heart Fail. 2011 Jan;13(1):18-28. doi: 10.1093/eurjhf/hfq121. Epub 2010 Aug 3.

    PubMed 20685685

  • Shah KS, Xu H, Matsouaka RA, Bhatt DL, Heidenreich PA, Hernandez AF, Devore AD, Yancy CW, Fonarow GC. Heart Failure With Preserved, Borderline, and Reduced Ejection Fraction: 5-Year Outcomes. J Am Coll Cardiol. 2017 Nov 14;70(20):2476-2486. doi: 10.1016/j.jacc.2017.08.074. Epub 2017 Nov 12.

    PubMed 29141781

  • Steinberg BA, Zhao X, Heidenreich PA, Peterson ED, Bhatt DL, Cannon CP, Hernandez AF, Fonarow GC; Get With the Guidelines Scientific Advisory Committee and Investigators. Trends in patients hospitalized with heart failure and preserved left ventricular ejection fraction: prevalence, therapies, and outcomes. Circulation. 2012 Jul 3;126(1):65-75. doi: 10.1161/CIRCULATIONAHA.111.080770. Epub 2012 May 21.

    PubMed 22615345

  • Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.

    PubMed 16855265

  • Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025. Epub 2017 Apr 28. No abstract available.

    PubMed 28461007

  • Dickstein K, Vardas PE, Auricchio A, Daubert JC, Linde C, McMurray J, Ponikowski P, Priori SG, Sutton R, van Veldhuisen DJ; ESC Committee for Practice Guidelines. 2010 Focused Update of ESC Guidelines on device therapy in heart failure: an update of the 2008 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC Guidelines for cardiac and resynchronization therapy. Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association. Europace. 2010 Nov;12(11):1526-36. doi: 10.1093/europace/euq392. No abstract available.

    PubMed 20974767

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

    PubMed 34447992

  • Ezekowitz JA, O'Meara E, McDonald MA, Abrams H, Chan M, Ducharme A, Giannetti N, Grzeslo A, Hamilton PG, Heckman GA, Howlett JG, Koshman SL, Lepage S, McKelvie RS, Moe GW, Rajda M, Swiggum E, Virani SA, Zieroth S, Al-Hesayen A, Cohen-Solal A, D'Astous M, De S, Estrella-Holder E, Fremes S, Green L, Haddad H, Harkness K, Hernandez AF, Kouz S, LeBlanc MH, Masoudi FA, Ross HJ, Roussin A, Sussex B. 2017 Comprehensive Update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure. Can J Cardiol. 2017 Nov;33(11):1342-1433. doi: 10.1016/j.cjca.2017.08.022. Epub 2017 Sep 6.

    PubMed 29111106

  • Chaudhry SI, Wang Y, Concato J, Gill TM, Krumholz HM. Patterns of weight change preceding hospitalization for heart failure. Circulation. 2007 Oct 2;116(14):1549-54. doi: 10.1161/CIRCULATIONAHA.107.690768. Epub 2007 Sep 10.

    PubMed 17846286

  • Metra M, Faggiano P, D'Aloia A, Nodari S, Gualeni A, Raccagni D, Dei Cas L. Use of cardiopulmonary exercise testing with hemodynamic monitoring in the prognostic assessment of ambulatory patients with chronic heart failure. J Am Coll Cardiol. 1999 Mar 15;33(4):943-50. doi: 10.1016/s0735-1097(98)00672-x.

    PubMed 10091820

  • Zile MR, Bennett TD, El Hajj S, Kueffer FJ, Baicu CF, Abraham WT, Bourge RC, Warner Stevenson L. Intracardiac Pressures Measured Using an Implantable Hemodynamic Monitor: Relationship to Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2017 Jan;10(1):e003594. doi: 10.1161/CIRCHEARTFAILURE.116.003594.

    PubMed 28062538

Questions about this trial

What is this clinical trial studying?

A study testing Greater Splanchnic Nerve Ablation in people with Heart Failure With Preserved Ejection Fraction (HFpEF, run by Axon Therapies, Inc. at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Judit Adorjan (16507221119, j.adorjan@axontherapies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint: Device or procedure related serious adverse events (time frame: 1 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04592445, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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