Evidence map›Paper›PMID 24846173›Full record

Trial reportEuropean journal of heart failure2014

Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF.

Gaetano M De Ferrari, Anton E Tuinenburg, Stephen Ruble, Josep Brugada, Helmut Klein, Christian Butter, David J Wright, Bernd Schubert, Scott Solomon, Scott Meyer and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in European journal of heart failure, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01385176 (Neural Cardiac Therapy for Heart Failure Study), which is not on this map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
6.6field-weighted citation impact, top 3% 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.

NCT01385176 naactive not recruitingnot on this map

Neural Cardiac Therapy for Heart Failure Study

TypeinterventionalSponsorBoston Scientific CorporationRan2011 to 2027Enrolled118ConditionsHeart Failure, Congestive Heart FailureArmsImplant of investigational device system, Titration during the randomization phase, Titration after the randomization phase, Blood Draw
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 63 citations in OpenAlex.

  1. Trial
  2. Timing Considerations for Noninvasive Vagal Nerve Stimulation in Clinical Studies.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2019
    Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Electroceuticals: Unlocking the promise of therapies.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2024
    Review
  11. Observational
  12. Review
  13. Article
  14. Article
  15. Clinical perspectives on vagus nerve stimulation: present and future.Clinical science (London, England : 1979) · 2022
    Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. 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

13 authors at 10 institutions in 8 countries.

Gaetano M De FerrariDepartment of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Anton E Tuinenburg
Stephen Ruble
Josep Brugada
Helmut Klein
Christian Butter
David J Wright
Bernd Schubert
Scott Solomon
Scott Meyer
Kenneth Stein
Agnes Ramuzat
Faiez Zannad
Boston Scientific (United States) · USChild Guidance Center · USRhythm (United states) · USCentre Hospitalier Régional et Universitaire de Nancy · FRHospital Clínic de Barcelona · ESIstituti di Ricovero e Cura a Carattere Scientifico · ITLiverpool Heart and Chest Hospital · GBOtto-von-Guericke University Magdeburg · DEUniversity Medical Center Utrecht · NLUniversity of Glasgow · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsIncreased sympathetic activation and reduced parasympathetic tone are important pathophysiological contributors to the progression of heart failure, and are associated with poor outcome in patients. The aim of this study is to determine if vagal nerve stimulation (VNS) is a promising approach to modulate autonomic function and slow cardiac remodelling and the progression of heart failure.

methodsThe NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) trial is designed to evaluate whether the Boston Scientific VNS device is safe and may attenuate cardiac remodelling, improve cardiac function and increase exercise capacity, in symptomatic heart failure patients (New York Heart Association Class II-III) with left ventricular systolic dysfunction (ejection fraction ≤35%) and receiving optimal medical therapy. Patients will be randomized in a 2:1 ratio to receive standard optimal medical treatment plus VNS system in an active mode vs. optimal medical treatment plus VNS system in an inactive mode, for a 6 month period. After the 6 month control period, inactive VNS systems will be activated and all patients will receive VNS. The study is powered to detect differences in the primary efficacy endpoint of change in left ventricular end systolic diameter. Secondary endpoints include ejection fraction, left ventricular volumes, quality of life scores, functional capacity, and changes in biomarkers.

conclusionThis Phase II, randomized clinical trial conducted with vagal stimulation for heart failure will provide important new information on the potential of this novel and promising technique.

Indexed as

BiomarkersDisease ProgressionEchocardiographyExercise TestFollow-Up StudiesHeart FailureHumansQuality of LifeResearch DesignStroke VolumeTreatment OutcomeVagus Nerve StimulationVentricular Dysfunction, LeftVentricular RemodelingBiomarkersAutonomicCardiacDeviceHeartParasympatheticVagal

Identifiers

PMID24846173
PMCPMC4288987
OpenAlexW1483704015

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.