HFpEF患者における右大内臓神経の血管内アブレーション (Rebalance-HF)
HFpEF を有する被験者における右大内臓神経の血管内アブレーションにおける右大内臓神経の血管内アブレーション
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Judit Adorjan
- 電話番号：16507221119
- メール：j.adorjan@axontherapies.com
研究連絡先のバックアップ
- 名前：Desiree McFee, MS
- 電話番号：6123568881
- メール：desiree@axontherapies.com
研究場所
-
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Alabama
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Birmingham、Alabama、アメリカ、35211
- 完了
- Cardiology PC
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-
Arizona
-
Phoenix、Arizona、アメリカ、85016
- 完了
- Arizona Cardiovascular Research Center
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-
California
-
La Jolla、California、アメリカ、92037
- 募集
- Scripps Health
-
主任研究者：
- Rajeev Mohan, MD
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主任研究者：
- Matthew Price, MD
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コンタクト：
- Stefania Marzano
- メール：marzano.stefania@scrippshealth.org
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San Francisco、California、アメリカ、94143
- 募集
- University of California, San Francisco
-
主任研究者：
- Liviu Klein, MD
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コンタクト：
- Priscilla Zhang
- 電話番号：415-514-7903
- メール：Priscilla.Zhang@ucsf.edu
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San Francisco、California、アメリカ、94143
- 募集
- Zuckerberg San Francisco General Hospital and Trauma Center
-
コンタクト：
- Kathrine (Kati) Steineman
- 電話番号：707-718-3130
- メール：katherine.steineman@ucsf.edu
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主任研究者：
- Lucas ZIer, MD
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Georgia
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Augusta、Georgia、アメリカ、30901
- まだ募集していません
- Piedmont
-
主任研究者：
- Darshak Karia, MD
-
コンタクト：
- Jennifer Hansen, RN
- 電話番号：706-724-2463
- メール：Jennifer.Hansen@piedmont.org
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コンタクト：
- Kimberly Allen, RN
- 電話番号：706-945-6961
- メール：kimberly.allen3@piedmont.org
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-
Illinois
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Chicago、Illinois、アメリカ、60611
- 募集
- Bluhm Cardiovascular Institute of Northwestern University
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主任研究者：
- Ravi Patel, MD
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コンタクト：
- Daniel Roshevsky
- メール：droshevs@nm.org
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Chicago、Illinois、アメリカ、60637
- 募集
- University of Chicago Medical Center
-
コンタクト：
- Adaeze Emeka
- メール：adaeze.emeka@bsd.uchicago.edu
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主任研究者：
- Mark Nathan Belkin, MD
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コンタクト：
- Nai Qashou
- メール：nai.qashou@bsd.uchicago.edu
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Springfield、Illinois、アメリカ、62701
- 完了
- Prairie Education and Research Cooperative
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-
Indiana
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Indianapolis、Indiana、アメリカ、46260
- 完了
- Ascension St. Vincent - Cardiovascular Research Institute
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-
Louisiana
-
Houma、Louisiana、アメリカ、70360
- 募集
- Cardiovascular Institute of the South
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主任研究者：
- Peter Fail, MD
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コンタクト：
- Kimberly Lirette
- メール：kimberly.lirette@cardio.com
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- 募集
- Michigan Medicine, University of Michigan
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主任研究者：
- Scott Hummel, MD
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コンタクト：
- Nikita Sawant Dessai
- メール：dessai@med.umich.edu
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-
Minnesota
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Rochester、Minnesota、アメリカ、55905
- 募集
- Mayo Clinic
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主任研究者：
- Barry Borlaug, MD
-
コンタクト：
- Annabelle Fuemffinger
- 電話番号：507-422-3801
- メール：Fuenffinger.Annabelle@mayo.edu
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Missouri
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St Louis、Missouri、アメリカ、63136
- 募集
- St. Louis Heart and Vascular
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主任研究者：
- Gil Vardi, MD
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コンタクト：
- Melissa McCann
- メール：mmccann@slhv.com
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-
New York
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New York、New York、アメリカ、10021
- 募集
- Weill Cornell Medicine
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主任研究者：
- Parag Goyal, MD
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コンタクト：
- Sara Kirschner
- メール：ski4008@med.cornell.edu
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New York、New York、アメリカ、10032
- 募集
- Columbia University Medical Center
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主任研究者：
- Nir Uriel, MD
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コンタクト：
- Benita Cui
- メール：bc3329@cumc.columbia.edu
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New York、New York、アメリカ、10029
- 完了
- Icahn School of Medicine at Mount Sinai
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Rochester、New York、アメリカ、14621
- 募集
- Rochester General Hospital
-
コンタクト：
- Kathleen Ebeling, RN
- メール：kathleen.ebeling@rochesterregional.org
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主任研究者：
- Vishal Parikh, DO
-
-
North Carolina
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Durham、North Carolina、アメリカ、27710
- 募集
- Duke University Medical Center
-
主任研究者：
- Marat Fudim, MD, MHS
-
コンタクト：
- Matthew Gray
- メール：james.gray@duke.edu
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Ohio
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Cincinnati、Ohio、アメリカ、45219
- まだ募集していません
- The Christ Hospital
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主任研究者：
- Odayme Quesada, MD
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コンタクト：
- Shelby Johnson
- 電話番号：513-585-4849
- メール：Shelby.Johnson@thechristhospital.com
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Columbus、Ohio、アメリカ、43210
- 募集
- Ohio State University Wexner Medical Center
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主任研究者：
- Alexandria Miller, MD
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コンタクト：
- Halle Woodruff
- メール：halle.woodruff@osumc.edu
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-
South Carolina
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Charleston、South Carolina、アメリカ、29425
- 募集
- Medical University of South Carolina
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主任研究者：
- Sheldon Litwin, MD
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コンタクト：
- Elly Borhanian
- メール：borhania@musc.edu
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Texas
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Houston、Texas、アメリカ、77030
- 募集
- Baylor College of Medicine
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主任研究者：
- Ajith Nair, MD
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コンタクト：
- Claudell Montano
- 電話番号：713-798-6832
- メール：claudell.montano@bcm.edu
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Virginia
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Richmond、Virginia、アメリカ、23298
- 完了
- Virginia Commonwealth University Medical Center
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-
-
-
-
Tbilisi、グルジア
- 募集
- Tbilisi Heart and Vascular Center
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主任研究者：
- Tamaz Shaburishvili, MD
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コンタクト：
- Teona Zirakashvili
- メール：zirakashvilit@gmail.com
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Tbilisi、グルジア
- 積極的、募集していない
- Tbilisi Heart Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
-
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:
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.
-
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.
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Age ≥40 years.
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Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
Exclusion Criteria:
-
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.
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Cardiac resynchronization therapy initiated within 3 months prior to screening.
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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.
- 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.
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Body mass index (BMI) >45 kg/m2.
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6-minute walk test distance <100 meters OR >450 meters.
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Admission for HF within the 30 days prior to planned index procedure.
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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.
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Orthostatic pulse pressure change from supine to standing decrease of >10mmHg in the absence of a HR increase >15bpm
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Postural orthostatic tachycardia syndrome or preload insufficiency syndrome.
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Systolic BP <100 mmHg or >170 mmHg despite appropriate medical management.
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Baseline screening ECG resting HR >100 beats per minute or ventricular tachycardia.
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Catheter ablation for atrial fibrillation within 6 months prior to screening or planned in the next 12 months at the time of screening.
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Left ventricular EF <40% within the 3 years prior to screening unless reduced EF was transient and associated with an acute event.
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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.
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Known hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).
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History of clinically significant liver cirrhosis.
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Prior weight loss surgery
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Dialysis dependent; or estimated GFR <25 ml/min/1.73 m2 by CKD-EPI creatinine equation.
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Arterial oxygen saturation <90% on room air.
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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).
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Participating in conflicting investigational drug or device study that is not completed within 30 days prior to the screening visit.
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Life expectancy <12 months for non-cardiovascular reasons.
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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.
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Females who are pregnant or lactating or planning to become pregnant during the next year.
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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
Exclusion Criteria Assessed During the index procedure:
-
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
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. |
|
偽コンパレータ：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary Safety Endpoint: Device or procedure related serious adverse events
時間枠：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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pulmonary Capillary Wedge Pressure (PCWP)
時間枠：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
時間枠：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
時間枠：Baseline through 24-months
|
Change in NT-proBNP levels from Baseline through the 24-month visit |
Baseline through 24-months
|
|
KCCQ (24-months)
時間枠：Baseline through 24-months
|
Change in KCCQ scores from baseline through the 24-month visit |
Baseline through 24-months
|
|
6MWT (24-months)
時間枠：Baseline through 24-months
|
Change in 6MWT from Baseline through the 24-month visit |
Baseline through 24-months
|
|
Time to first heart failure event
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：Procedure through 12- and 24-months
|
Incidence of all Adverse Events through 12- and 24-months |
Procedure through 12- and 24-months
|
|
Mortality
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exploratory endpoint: Heart failure related medication changes (24-months)
時間枠：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)
時間枠：Baseline through 24-months
|
Change in diuretic dose through the 24-month visit |
Baseline through 24-months
|
|
Exploratory Endpoint: Diastolic function (24-months)
時間枠：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
時間枠：Baseline through 24-months
|
Change in c-reactive protein levels from Baseline through 24-months |
Baseline through 24-months
|
|
Exploratory Endpoint: Aldosterone (ALD)
時間枠：Baseline through 24-months
|
Change in aldosterone levels from Baseline through 24-months |
Baseline through 24-months
|
|
Exploratory Endpoint: Renin
時間枠：Baseline through 24-months
|
Change in Renin levels from Baseline through 24-months |
Baseline through 24-months
|
|
Exploratory Endpoint: Weight
時間枠：Baseline through 24-months
|
Change in weight from Baseline through 24-months |
Baseline through 24-months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sanjiv S Shah, MD、Northwestern University
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med. 1999 Jun 15;18(11):1341-54. doi: 10.1002/(sici)1097-0258(19990615)18:113.0.co;2-7.
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- Borlaug BA, Nishimura RA, Sorajja P, Lam CS, Redfield MM. Exercise hemodynamics enhance diagnosis of early heart failure with preserved ejection fraction. Circ Heart Fail. 2010 Sep;3(5):588-95. doi: 10.1161/CIRCHEARTFAILURE.109.930701. Epub 2010 Jun 11.
- 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.
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