Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of a procedure that uses a thin tube and the Satera Ablation System to treat the right greater splanchnic nerve. It looks for early signs that the treatment may ease symptoms in people with heart failure with preserved ejection fraction (HFpEF), where the heart still pumps out a normal share of blood.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 40 or older.
- Have long-term heart failure treated with water pills for more than 30 days.
- Have the required level of heart failure symptoms or signs, such as trouble breathing with activity or fluid in the lungs.
- Have at least one of these: a heart failure hospital stay or urgent IV water pill treatment in the past year, high heart failure blood test levels, or high heart filling pressure on a test.
- Have a heart ultrasound from the past 6 months showing an ejection fraction of at least 50%. This is the share of blood pumped out with each beat.
- Have stable, recommended care for heart failure and related health problems, unless you cannot tolerate it. Treatment must have no major changes for at least 30 days and be expected to stay unchanged for at least 6 months.
- Have not started a GLP-1 or GIP drug in the past 6 months and do not plan to start one in the 6 months after joining.
- Be willing and able to give consent, follow study steps, and attend follow-up visits.
Who can't join
- Recent heart attack, heart artery procedure, bypass surgery, or start of special heart pacing treatment; a current need for heart artery treatment; or a heart failure hospital stay within 30 days before the study procedure.
- Very advanced heart failure, recent IV drugs to help the heart pump, a heart transplant waiting list placement, or past or current use of a heart pump device. Certain heart muscle, valve, filling, or right-heart problems also rule out joining.
- Blood pressure that drops when standing, certain standing-related pulse changes, or problems with blood returning to the heart. Also excluded: top blood pressure below 100 or above 170 despite treatment, resting pulse above 100, or a dangerous rhythm in the heart’s lower chambers.
- A procedure to treat atrial fibrillation, an irregular heartbeat, in the past 6 months or planned in the next 12 months. A heart pumping measure below 40% in the past 3 years also rules out joining, unless it was temporary and linked to a sudden illness or event.
- Body mass index (BMI) above 45, prior weight-loss surgery, or walking less than 100 or more than 450 meters in 6 minutes.
- Serious liver scarring, dialysis or severe kidney problems, blood oxygen below 90% without extra oxygen, or certain severe lung problems, including needing constant home oxygen.
- Pregnancy, breastfeeding, or plans to become pregnant in the next year; a conflicting research study; expected survival under 12 months for reasons unrelated to the heart; or another condition that could make the study unsafe or affect its results.
- Heart catheter test results showing certain high pressures, low blood flow, or high resistance in lung blood vessels. Blood vessel shape or past spine surgery that prevents safe access to the treatment site also rules out joining.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (24)
AL
- Cardiology PC · Birmingham, AL 35211More trials in Birmingham
AZ
- Arizona Cardiovascular Research Center · Phoenix, AZ 85016More trials in Phoenix
CA
- Scripps Health · La Jolla, CA 92037Stefania Marzano · Study contact · marzano.stefania@scrippshealth.orgRajeev Mohan, MD · Principal investigatorMatthew Price, MD · Principal investigatorMore trials in La Jolla
- University of California, San Francisco · San Francisco, CA 94143Priscilla Zhang · Study contact · 415-514-7903 · Priscilla.Zhang@ucsf.eduLiviu Klein, MD · Principal investigatorMore trials in San Francisco
- Zuckerberg San Francisco General Hospital and Trauma Center · San Francisco, CA 94143Kathrine (Kati) Steineman · Study contact · 707-718-3130 · katherine.steineman@ucsf.eduLucas ZIer, MD · Principal investigatorMore trials in San Francisco
GA
- Piedmont · Augusta, GA 30901Jennifer Hansen, RN · Study contact · 706-724-2463 · Jennifer.Hansen@piedmont.orgKimberly Allen, RN · Study contact · 706-945-6961 · kimberly.allen3@piedmont.orgDarshak Karia, MD · Principal investigatorMore trials in Augusta
IL
- Bluhm Cardiovascular Institute of Northwestern University · Chicago, IL 60611Daniel Roshevsky · Study contact · droshevs@nm.orgRavi Patel, MD · Principal investigatorMore trials in Chicago
- University of Chicago Medical Center · Chicago, IL 60637Adaeze Emeka · Study contact · adaeze.emeka@bsd.uchicago.eduNai Qashou · Study contact · nai.qashou@bsd.uchicago.eduMark Nathan Belkin, MD · Principal investigatorMore trials in Chicago
- Prairie Education and Research Cooperative · Springfield, IL 62701More trials in Springfield
IN
- Ascension St. Vincent - Cardiovascular Research Institute · Indianapolis, IN 46260More trials in Indianapolis
LA
- Cardiovascular Institute of the South · Houma, LA 70360Kimberly Lirette · Study contact · kimberly.lirette@cardio.comPeter Fail, MD · Principal investigatorMore trials in Houma
MI
- Michigan Medicine, University of Michigan · Ann Arbor, MI 48109Nikita Sawant Dessai · Study contact · dessai@med.umich.eduScott Hummel, MD · Principal investigatorMore trials in Ann Arbor
MN
- Mayo Clinic · Rochester, MN 55905Annabelle Fuemffinger · Study contact · 507-422-3801 · Fuenffinger.Annabelle@mayo.eduBarry Borlaug, MD · Principal investigatorMore trials in Rochester
MO
- St. Louis Heart and Vascular · St Louis, MO 63136Melissa McCann · Study contact · mmccann@slhv.comGil Vardi, MD · Principal investigatorMore trials in St Louis
NC
- Duke University Medical Center · Durham, NC 27710Matthew Gray · Study contact · james.gray@duke.eduMarat Fudim, MD, MHS · Principal investigatorMore trials in Durham
NY
- Weill Cornell Medicine · New York, NY 10021Sara Kirschner · Study contact · ski4008@med.cornell.eduParag Goyal, MD · Principal investigatorMore trials in New York
- Icahn School of Medicine at Mount Sinai · New York, NY 10029More trials in New York
- Columbia University Medical Center · New York, NY 10032Benita Cui · Study contact · bc3329@cumc.columbia.eduNir Uriel, MD · Principal investigatorMore trials in New York
- Rochester General Hospital · Rochester, NY 14621Kathleen Ebeling, RN · Study contact · kathleen.ebeling@rochesterregional.orgVishal Parikh, DO · Principal investigatorMore trials in Rochester
OH
- The Christ Hospital · Cincinnati, OH 45219Shelby Johnson · Study contact · 513-585-4849 · Shelby.Johnson@thechristhospital.comOdayme Quesada, MD · Principal investigatorMore trials in Cincinnati
- Ohio State University Wexner Medical Center · Columbus, OH 43210Halle Woodruff · Study contact · halle.woodruff@osumc.eduAlexandria Miller, MD · Principal investigatorMore trials in Columbus
SC
- Medical University of South Carolina · Charleston, SC 29425Elly Borhanian · Study contact · borhania@musc.eduSheldon Litwin, MD · Principal investigatorMore trials in Charleston
TX
- Baylor College of Medicine · Houston, TX 77030Claudell Montano · Study contact · 713-798-6832 · claudell.montano@bcm.eduAjith Nair, MD · Principal investigatorMore trials in Houston
VA
- Virginia Commonwealth University Medical Center · Richmond, VA 23298More trials in Richmond