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Oikean suuren splanchnisen hermon endovaskulaarinen ablaatio potilailla, joilla on HFpEF (Rebalance-HF)

keskiviikko 16. syyskuuta 2026 päivittänyt: Axon Therapies, Inc.

OIKEAN SUUREMMAN SIIRTOHERMOON ENDOVASKULAARINEN ABLATIO Oikean suuren splanchnisen hermon endovaskulaarisessa ablaatiossa potilailla, joilla on HFpEF: Toteutettavuustutkimus: Satunnaistettu kontrolloitu toteutettavuuskoe – HF-tasapainotutkimus

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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

150

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Opiskelupaikat

  • Georgia
      • Tbilisi, Georgia
        • Rekrytointi
        • Tbilisi Heart and Vascular Center
        • Päätutkija:
          • Tamaz Shaburishvili, MD
        • Ottaa yhteyttä:
      • Tbilisi, Georgia
        • Aktiivinen, ei rekrytointi
        • Tbilisi Heart Center
  • Yhdysvallat
    • Alabama
      • Birmingham, Alabama, Yhdysvallat, 35211
        • Valmis
        • Cardiology PC
    • Arizona
      • Phoenix, Arizona, Yhdysvallat, 85016
        • Valmis
        • Arizona Cardiovascular Research Center
    • California
      • La Jolla, California, Yhdysvallat, 92037
        • Rekrytointi
        • Scripps Health
        • Päätutkija:
          • Rajeev Mohan, MD
        • Päätutkija:
          • Matthew Price, MD
        • Ottaa yhteyttä:
      • San Francisco, California, Yhdysvallat, 94143
        • Rekrytointi
        • University of California, San Francisco
        • Päätutkija:
          • Liviu Klein, MD
        • Ottaa yhteyttä:
      • San Francisco, California, Yhdysvallat, 94143
        • Rekrytointi
        • Zuckerberg San Francisco General Hospital and Trauma Center
        • Ottaa yhteyttä:
        • Päätutkija:
          • Lucas ZIer, MD
    • Georgia
      • Augusta, Georgia, Yhdysvallat, 30901
        • Ei vielä rekrytointia
        • Piedmont
        • Päätutkija:
          • Darshak Karia, MD
        • Ottaa yhteyttä:
        • Ottaa yhteyttä:
    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60611
        • Rekrytointi
        • Bluhm Cardiovascular Institute of Northwestern University
        • Päätutkija:
          • Ravi Patel, MD
        • Ottaa yhteyttä:
      • Chicago, Illinois, Yhdysvallat, 60637
      • Springfield, Illinois, Yhdysvallat, 62701
        • Valmis
        • Prairie Education and Research Cooperative
    • Indiana
      • Indianapolis, Indiana, Yhdysvallat, 46260
        • Valmis
        • Ascension St. Vincent - Cardiovascular Research Institute
    • Louisiana
      • Houma, Louisiana, Yhdysvallat, 70360
        • Rekrytointi
        • Cardiovascular Institute of the South
        • Päätutkija:
          • Peter Fail, MD
        • Ottaa yhteyttä:
    • Michigan
      • Ann Arbor, Michigan, Yhdysvallat, 48109
        • Rekrytointi
        • Michigan Medicine, University of Michigan
        • Päätutkija:
          • Scott Hummel, MD
        • Ottaa yhteyttä:
    • Minnesota
      • Rochester, Minnesota, Yhdysvallat, 55905
        • Rekrytointi
        • Mayo Clinic
        • Päätutkija:
          • Barry Borlaug, MD
        • Ottaa yhteyttä:
    • Missouri
      • St Louis, Missouri, Yhdysvallat, 63136
        • Rekrytointi
        • St. Louis Heart and Vascular
        • Päätutkija:
          • Gil Vardi, MD
        • Ottaa yhteyttä:
    • New York
      • New York, New York, Yhdysvallat, 10021
        • Rekrytointi
        • Weill Cornell Medicine
        • Päätutkija:
          • Parag Goyal, MD
        • Ottaa yhteyttä:
      • New York, New York, Yhdysvallat, 10032
        • Rekrytointi
        • Columbia University Medical Center
        • Päätutkija:
          • Nir Uriel, MD
        • Ottaa yhteyttä:
      • New York, New York, Yhdysvallat, 10029
        • Valmis
        • Icahn School of Medicine at Mount Sinai
      • Rochester, New York, Yhdysvallat, 14621
    • North Carolina
      • Durham, North Carolina, Yhdysvallat, 27710
        • Rekrytointi
        • Duke University Medical Center
        • Päätutkija:
          • Marat Fudim, MD, MHS
        • Ottaa yhteyttä:
    • Ohio
      • Cincinnati, Ohio, Yhdysvallat, 45219
        • Ei vielä rekrytointia
        • The Christ Hospital
        • Päätutkija:
          • Odayme Quesada, MD
        • Ottaa yhteyttä:
      • Columbus, Ohio, Yhdysvallat, 43210
        • Rekrytointi
        • Ohio State University Wexner Medical Center
        • Päätutkija:
          • Alexandria Miller, MD
        • Ottaa yhteyttä:
    • South Carolina
      • Charleston, South Carolina, Yhdysvallat, 29425
        • Rekrytointi
        • Medical University of South Carolina
        • Päätutkija:
          • Sheldon Litwin, MD
        • Ottaa yhteyttä:
    • Texas
      • Houston, Texas, Yhdysvallat, 77030
        • Rekrytointi
        • Baylor College of Medicine
        • Päätutkija:
          • Ajith Nair, MD
        • Ottaa yhteyttä:
    • Virginia
      • Richmond, Virginia, Yhdysvallat, 23298
        • Valmis
        • Virginia Commonwealth University Medical Center

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

40 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria

  1. Chronic heart failure, defined as:

    1. Symptoms of HF requiring current (intermittent or continuous) treatment with diuretics for >30 days, AND
    2. 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
    3. At least one of the following:

    i. ≥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.

  2. 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.

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

  4. Age ≥40 years.

  5. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.

Exclusion Criteria:

  1. 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.

  2. Cardiac resynchronization therapy initiated within 3 months prior to screening.

  3. Advanced heart failure defined as one or more of the following:

    1. ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.
    2. Inotropic infusion (continuous or intermittent) within 6 months prior to screening.
    3. Subject is on the cardiac transplant waiting list.
    4. Presence of or prior history of mechanical circulatory support for HF.

  4. 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.

  5. 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.

  6. Body mass index (BMI) >45 kg/m2.

  7. 6-minute walk test distance <100 meters OR >450 meters.

  8. Admission for HF within the 30 days prior to planned index procedure.

  9. 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.

  10. Orthostatic pulse pressure change from supine to standing decrease of >10mmHg in the absence of a HR increase >15bpm

  11. Postural orthostatic tachycardia syndrome or preload insufficiency syndrome.

  12. Systolic BP <100 mmHg or >170 mmHg despite appropriate medical management.

  13. Baseline screening ECG resting HR >100 beats per minute or ventricular tachycardia.

  14. Catheter ablation for atrial fibrillation within 6 months prior to screening or planned in the next 12 months at the time of screening.

  15. Left ventricular EF <40% within the 3 years prior to screening unless reduced EF was transient and associated with an acute event.

  16. Presence of significant valve disease defined by the site cardiologist as:

    1. Greater than mild mitral valve stenosis.
    2. Greater than moderate mitral valve regurgitation.
    3. Greater than moderate-to-severe tricuspid valve regurgitation.
    4. Greater than moderate aortic valve stenosis or regurgitation.

  17. Known hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).

  18. History of clinically significant liver cirrhosis.

  19. Prior weight loss surgery

  20. Dialysis dependent; or estimated GFR <25 ml/min/1.73 m2 by CKD-EPI creatinine equation.

  21. Arterial oxygen saturation <90% on room air.

  22. 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).

  23. Participating in conflicting investigational drug or device study that is not completed within 30 days prior to the screening visit.

  24. Life expectancy <12 months for non-cardiovascular reasons.

  25. 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.

  26. Females who are pregnant or lactating or planning to become pregnant during the next year.

  27. Any of the following measured by screening right heart catheterization:

    1. Mean right atrial pressure (RAP) >20 mmHg at rest
    2. Cardiac index <2.0 L/min/m2 at rest
    3. Pulmonary vascular resistance (PVR) >4 Wood units

    Exclusion Criteria Assessed During the index procedure:

  28. 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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: Greater Splanchnic Nerve Ablation

After 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.
Laite: Greater Splanchnic Nerve Ablation

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.
Huijausvertailija: Sham Control Arm

After 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.
Laite: Sham Control

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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Primary Safety Endpoint: Device or procedure related serious adverse events
Aikaikkuna: 1 Month

Evaluation of device or procedure-related serious adverse events at 1-month follow-up based on Clinical Events Committee (CEC) assessment
1 Month
Primary Efficacy Endpoint: KCCQ (6 months)
Aikaikkuna: Baseline through 6-months

Assessment of change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6-month follow up visit
Baseline through 6-months
Primary Efficacy Endpoint: 6MWT (6 months)
Aikaikkuna: Baseline through 6 months

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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Pulmonary Capillary Wedge Pressure (PCWP)
Aikaikkuna: Baseline through 1-month

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
Baseline through 1-month
Stress blood volume
Aikaikkuna: Baseline through 1-month

Change in estimated stress blood volume at resting, legs up, 20Watts, and Peak Exercise Stage from Baseline to the 1-month follow up visit.
Baseline through 1-month
NT-proBNP
Aikaikkuna: Baseline through 24-months

Change in NT-proBNP levels from Baseline through the 24-month visit
Baseline through 24-months
KCCQ (24-months)
Aikaikkuna: Baseline through 24-months

Change in KCCQ scores from baseline through the 24-month visit
Baseline through 24-months
6MWT (24-months)
Aikaikkuna: Baseline through 24-months

Change in 6MWT from Baseline through the 24-month visit
Baseline through 24-months
Time to first heart failure event
Aikaikkuna: Treatment through 24-months

Time to first heart failure event (hospitalizations and worsening heart failure events) through the 24-month visit
Treatment through 24-months
Incidence of heart failure events
Aikaikkuna: Treatment through 24-months

Incidence of heart failure events (hospitalizations and worsening heart failure events) through the 24-month visit
Treatment through 24-months
Hierarchical composite endpoint (12-months)
Aikaikkuna: Baseline through 12-months

Composite endpoint of cardiovascular death, heart failure events, and changes in KCCQ from Baseline to the 12-month visit
Baseline through 12-months
Incidence of serious device related cardiac or vascular events
Aikaikkuna: Treatment through 12- and 24-months

Assessment of the incidence of serious device related cardiac or vascular events through 12- and 24-months
Treatment through 12- and 24-months
Device or procedure related pain
Aikaikkuna: Treatment through 24-months

Assessment of device or procedure related pain lasting at least 30 days and requiring medical management
Treatment through 24-months
Orthostatic hypotension
Aikaikkuna: Treatment through 12- and 24-months

Incidence of new orthostatic hypotension up to 12- and 24-months
Treatment through 12- and 24-months
Acute Kidney Injury (AKI)
Aikaikkuna: Baseline through 12-and 24-months

Incidence of AKI requiring renal replacement therapy up to 12- and 24-months
Baseline through 12-and 24-months
Glomerular Filtration Rate (GFR)
Aikaikkuna: Baseline through 12- and 24-months

Incidence of worsening GFR (defined as >50% for at least 30 days in duration) up to 12- and 24-months
Baseline through 12- and 24-months
Adverse Events
Aikaikkuna: Procedure through 12- and 24-months

Incidence of all Adverse Events through 12- and 24-months
Procedure through 12- and 24-months
Mortality
Aikaikkuna: Procedure through 6-, 12- and 24-months

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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Exploratory endpoint: Heart failure related medication changes (24-months)
Aikaikkuna: Baseline through 24-months

Freedom from heart failure related medication changes through the 24-month visit
Baseline through 24-months
Exploratory Endpoint: Diuretic medication (24-months)
Aikaikkuna: Baseline through 24-months

Change in diuretic dose through the 24-month visit
Baseline through 24-months
Exploratory Endpoint: Diastolic function (24-months)
Aikaikkuna: Baseline through 24-months

Assessment of diastolic function by transthoracic echocardiography evaluated over time from baseline through 24-months
Baseline through 24-months
Exploratory Endpoint: C-reactive protein
Aikaikkuna: Baseline through 24-months

Change in c-reactive protein levels from Baseline through 24-months
Baseline through 24-months
Exploratory Endpoint: Aldosterone (ALD)
Aikaikkuna: Baseline through 24-months

Change in aldosterone levels from Baseline through 24-months
Baseline through 24-months
Exploratory Endpoint: Renin
Aikaikkuna: Baseline through 24-months

Change in Renin levels from Baseline through 24-months
Baseline through 24-months
Exploratory Endpoint: Weight
Aikaikkuna: Baseline through 24-months

Change in weight from Baseline through 24-months
Baseline through 24-months

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Axon Therapies, Inc.

Yhteistyökumppanit

Northwestern University
NAMSA
Cardiovascular Research Foundation, New York

Tutkijat

  • Päätutkija: Sanjiv S Shah, MD, Northwestern University

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Perjantai 10. elokuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 7. lokakuuta 2020

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 13. lokakuuta 2020

Ensimmäinen Lähetetty (Todellinen)

Maanantai 19. lokakuuta 2020

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 21. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 16. syyskuuta 2026

Viimeksi vahvistettu

Tiistai 1. syyskuuta 2026

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