Evidence map›Paper›PMID 33992562›Full record

Trial reportJACC. Heart failure2021

Response by Sex in Patient-Centered Outcomes With Baroreflex Activation Therapy in Systolic Heart Failure.

JoAnn Lindenfeld, Richa Gupta, Luanda Grazette, Jean Marie Ruddy, Lana Tsao, Elizabeth Galle, Tyson Rogers, Samuel Sears, Faiez Zannad

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JACC. Heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02627196 (Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 16% of its field
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.

NCT02627196 nacompletednot on this map

Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure

TypeinterventionalSponsorCVRx, Inc.Ran2016 to 2023Enrolled1,090ConditionsHeart FailureArmsBAROSTIM NEO® System, Medical Management
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Neuromodulation devices for heart failureEuropean heart journal supplements : journal of the European Society of Cardiology · 2022
    Article
  5. Article
  6. Review
  7. 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

9 authors at 8 institutions in 2 countries.

JoAnn LindenfeldDivision of Cardiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA. Electronic address: joann.lindenfeld@vumc.org.
Richa GuptaDivision of Cardiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Luanda GrazetteKeck School of Medicine, University of Southern California, Los Angeles, California, USA.
Jean Marie RuddyMedical University of South Carolina, Charleston, South Carolina, USA.
Lana TsaoSaint Elizabeth's Medical Center, Boston, Massachusetts, USA.
Elizabeth GalleCVRx, Minneapolis, Minnesota, USA.
Tyson RogersNAMSA, Minneapolis, Minnesota, USA.
Samuel SearsEast Carolina State University, Greenville, North Carolina, USA.
Faiez ZannadInserm Centre d'Investigation, CHU de Nancy, Institute Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France.
Vanderbilt University Medical Center · USCVRx (United States) · USEast Carolina University · USInserm · FRMedical University of South Carolina · USNational Alliance on Mental Illness · USSt. Elizabeth's Medical Center · USUniversity of Southern California · US

Funding

Tension-induced SGK-1 Signaling in AAAK08HL143169 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI RUDDY, JEAN MARIE · 2019 to 2023
$882k
NHLBI NIH HHS K08 HL143169
6 · The paper itself

Abstract

objectivesThe aim of this study was to assess sex differences in the efficacy and safety of baroreflex activation therapy (BAT) in the BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial.

backgroundPatients were randomized 1:1 to receive guideline-directed medical therapy (GDMT) alone (control group) or BAT plus GDMT.

methodsPre-specified subgroup analyses including change from baseline to 6 months in 6-min walk distance (6MWD), quality of life (QoL) assessed using the Minnesota Living With Heart Failure Questionnaire (MLWHQ), New York Heart Association (NYHA) functional class, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) were conducted in men versus women.

resultsFifty-three women and 211 men were evaluated. Women had similar baseline NT-proBNP levels, 6MWDs, and percentage of subjects with NYHA functional class III symptoms but poorer MLWHQ scores (mean 62 ± 22 vs. 50 ± 24; p = 0.01) compared with men. Women experienced significant improvement from baseline to 6 months with BAT plus GDMT relative to GDMT alone in MLWHQ score (-34 ± 27 vs. -9 ± 23, respectively; p < 0.01), 6MWD (44 ± 45 m vs. -32 ± 118 m; p < 0.01), and improvement in NYHA functional class (70% vs. 27%; p < 0.01), similar to the responses seen in men, with no significant difference in safety. Women receiving BAT plus GDMT had a significant decrease in NT-proBNP (-43% vs. 7% with GDMT alone; difference -48%; p < 0.01), while in men this decrease was -15% versus 2%, respectively (difference -17%; p = 0.08), with an interaction p value of 0.05.

conclusionsWomen in BeAT-HF had poorer baseline QoL than men but demonstrated similar improvements with BAT in 6MWD, QoL, and NYHA functional class. Women had a significant improvement in NT-proBNP, whereas men did not. (Baroreflex Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196).

Indexed as

Electric Stimulation TherapyHeart FailureHeart Failure, SystolicBaroreflexFemaleHumansMaleNatriuretic Peptide, BrainPatient-Centered CarePeptide FragmentsQuality of LifeStroke VolumeNatriuretic Peptide, BrainPeptide Fragmentsbaroreflexcongestiveheart failure

Identifiers

PMID33992562
PMCPMC8852222
OpenAlexW3162663685

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.