Evidence map›Paper›PMID 35598154›Full record

Trial reportEuropean journal of heart failure2022

Endovascular ablation of the right greater splanchnic nerve in heart failure with preserved ejection fraction: early results of the REBALANCE-HF trial roll-in cohort.

Marat Fudim, Peter S Fail, Sheldon E Litwin, Tamaz Shaburishvili, Parag Goyal, Scott L Hummel, Barry A Borlaug, Rajeev C Mohan, Ravi B Patel, Sumeet S Mitter and 6 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of heart failure, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04592445 narecruitingnot on this map

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

TypeinterventionalSponsorAxon Therapies, Inc.Ran2020 to 2029Enrolled150ConditionsHeart Failure With Preserved Ejection Fraction (HFpEFArmsGreater Splanchnic Nerve Ablation, Sham Control
NCT07403058 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Endovascular Ablation Of The Right Greater Splanchnic Nerve In Subjects Having Heart Failure With Reduced Ejection Fraction: Randomized Controlled Feasibility Trial

TypeinterventionalSponsorAxon Therapies, Inc.Ran2026 to 2028Enrolled50ConditionsHeart Failure With Reduced Ejection Fraction (HFrEF)ArmsRight Greater Splanchnic Nerve (GSN) ablation, Sham Control
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  11. 2024 update in heart failure.ESC heart failure · 2025
    Review
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  13. Article
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  20. Recent advances in cardiac anaesthesia.Indian journal of anaesthesia · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Marat FudimDuke University Medical Center, Durham, NC, USA.
Peter S FailCardiovascular Institute of the South, Houma, LA, USA.
Sheldon E LitwinMedical University of South Carolina and Ralph H. Johnson, Veterans Affairs Medical Center, Charleston, SC, USA.
Tamaz ShaburishviliTbilisi Heart and Vascular Clinic, Tbilisi, Georgia.
Parag GoyalWeill Cornell Medicine, New Yok, NY, USA.
Scott L HummelMichigan School of Medicine, University of Michigan, Ann Arbor, MI, USA.
Barry A BorlaugMayo Clinic, College of Medicine, Rochester, MN, USA.
Rajeev C MohanScripps Clinic, La Jolla, CA, USA.
Ravi B PatelNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Sumeet S MitterMount Sinai Hospital - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Liviu KleinUniversity of California San Francisco, San Francisco, CA, USA.
Krishna Rocha-SinghPrairie Heart Institute at St. John's Hospital, Springfield, IL, USA.
Manesh R PatelDuke University Medical Center, Durham, NC, USA.
Vivek Y ReddyMount Sinai Hospital - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Daniel BurkhoffCardiovascular Research Foundation, New York, NY, USA.
Sanjiv J ShahNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.

Funding

HeartShare DeCODE-HF: Data translation center to Combine Omics, Deep phenotyping, and Electronic health records for Heart Failure subtypes and treatment targetsU54HL160273 · NHLBI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Abel N. Kho, Yuan Luo · 2021 to 2026
$19.0M
Transition from Risk Factors to Early HF: Prevalence, Pathogenesis, and PhenomicsR01HL127028 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI BERTONI, ALAIN GERALD, SHAH, SANJIV J · 2015 to 2018
$6.5M
Study of Cardiac Mechanics in Systemic HypertensionR01HL107577 · NHLBI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI SHAH, SANJIV J · 2011 to 2019
$4.1M
Machine learning for the automated identification and tracking of rare myocardial diseasesR01HL140731 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MACRAE, CALUM A., SHAH, SANJIV J · 2018 to 2021
$2.8M
NHLBI NIH HHS R01 HL107577NHLBI NIH HHS R01 HL127028NHLBI NIH HHS R01 HL140731NHLBI NIH HHS U54 HL160273
6 · The paper itself

Abstract

aimsIn heart failure (HF) with preserved ejection fraction (HFpEF), excessive redistribution of blood volume into the central circulation leads to elevations of intracardiac pressures with exercise limitations. Splanchnic ablation for volume management (SAVM) has been proposed as a therapeutic intervention. Here we present preliminary safety and efficacy data from the initial roll-in cohort of the REBALANCE-HF trial. METHODS AND

resultsThe open-label (roll-in) arm of REBALANCE-HF will enrol up to 30 patients, followed by the randomized, sham-controlled portion of the trial (up to 80 additional patients). Patients with HF, left ventricular ejection fraction (LVEF) ≥50%, and invasive peak exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg underwent SAVM. Baseline and follow-up assessments included resting and exercise PCWP, New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-min walk test, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Efficacy and safety were assessed at 1 and 3 months. Here we report on the first 18 patients with HFpEF that have been enrolled into the roll-in, open-label arm of the study across nine centres; 14 (78%) female; 16 (89%) in NYHA class III; and median (interquartile range) age 75.2 (68.4-81) years, LVEF 61.0 (56.0-63.2)%, and average (standard deviation) 20 W exercise PCWP 36.4 (±8.6) mmHg. All 18 patients were successfully treated. Three non-serious moderate device/procedure-related adverse events were reported. At 1-month, the mean PCWP at 20 W exercise decreased from 36.4 (±8.6) to 28.9 (±7.8) mmHg (p < 0.01), NYHA class improved by at least one class in 33% of patients (p = 0.02) and KCCQ score improved by 22.1 points (95% confidence interval 9.4-34.2) (p < 0.01).

conclusionThe preliminary open-label results from the multicentre REBALANCE-HF roll-in cohort support the safety and efficacy of SAVM in HFpEF. The findings require confirmation in the ongoing randomized, sham-controlled portion of the trial.

Indexed as

Heart FailureAgedFemaleHumansMalePulmonary Wedge PressureSplanchnic NervesStroke VolumeVentricular Function, LeftClinical trialHeart failure with preserved ejection fractionSplanchnic nerve ablationTherapeutics

Identifiers

PMID35598154
PMCPMC9388552

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.