Evidence map›Paper›PMID 34784359›Full record

Observational studyPloS one2021

Endovascular baroreflex amplification and the effect on sympathetic nerve activity in patients with resistant hypertension: A proof-of-principle study.

Monique E A M van Kleef, Karsten Heusser, André Diedrich, P Liam Oey, Jens Tank, Jens Jordan, Peter J Blankestijn, Bryan Williams, Wilko Spiering

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02827032 (Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 12% 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.

NCT02827032 naunknown statusnot on this map

Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers

TypeinterventionalSponsorVascular Dynamics, Inc.Ran2016 to 2026Enrolled200ConditionsHypertensionArmsMobiusHD™
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Hypertension: a lymphatic disease?Clinical science (London, England : 1979) · 2025
    Review
  5. Review
  6. Review
  7. Case report: acute vestibular syndrome following a small infarct on the right dorsolateral putamen.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  8. The coming era of neuromodulation therapies: expectations for baroreceptor stimulation.Hypertension research : official journal of the Japanese Society of Hypertension · 2024
    Article
  9. Device-Based Therapy for Resistant Hypertension: An Up-to-Date Review.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2022
    Review
  10. 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 4 institutions in 4 countries.

Monique E A M van KleefDepartment of Vascular Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.
Karsten HeusserInstitute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.ORCID 0000-0002-2571-5585
André DiedrichDivision of Clinical Pharmacology, Department of Medicine, Autonomic Dysfunction Center, Vanderbilt University Medical Center, Nashville, TN, United States of America.
P Liam OeyDepartment of Nephrology, University Medical Center Utrecht, Utrecht, The Netherlands.
Jens TankInstitute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.
Jens JordanInstitute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.
Peter J BlankestijnDepartment of Nephrology, University Medical Center Utrecht, Utrecht, The Netherlands.
Bryan WilliamsUniversity College London (UCL) Institute of Cardiovascular Science and National Institute for Health Research (NIHR) UCL Hospitals Biomedical Research Centre, London, United Kingdom.
Wilko SpieringDepartment of Vascular Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID 0000-0002-2493-6407
University Medical Center Utrecht · NLDeutsches Zentrum für Luft- und Raumfahrt e. V. (DLR) · DENational Institute for Health Research · GBVanderbilt University Medical Center · US

Funding

Structural genomics of norepinephrine transportersP01HL056693 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ROBERTSON, DAVID HERLIE · 1997 to 2016
$30.8M
Autonomic Determinants of Postural Tachycardia SyndromeR01HL142583 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DIEDRICH, ANDRE · 2019 to 2022
$1.7M
Autonomic Determinants of Postural Tachycardia SyndromeR56HL142583 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DIEDRICH, ANDRE · 2018 to 2018
$391k
Department of HealthNHLBI NIH HHS P01 HL056693NHLBI NIH HHS R01 HL142583NHLBI NIH HHS R56 HL142583
6 · The paper itself

Abstract

backgroundFirst in human studies suggest that endovascular baroreflex amplification (EVBA) lowers blood pressure (BP). To explore potential mechanisms for BP reduction, this study examines the effects of EVBA on muscle sympathetic nerve activity (MSNA) and baroreceptor sensitivity (BRS).

methodsIn a single-center sub-study of the CALM-DIEM study (Controlling And Lowering blood pressure with the MobiusHD-Defining Efficacy Markers), 14 patients with resistant hypertension were treated with EVBA. Microneurography and non-invasive continuous BP measurements were performed at baseline and three months after MobiusHD implantation. The primary outcome was change in MSNA. Secondary outcomes were change in baroreflex sensitivity (BRS), cardiovascular responses to a sympathetic stimulus, BP, heart rate (HR) and heart rate variability (HRV).

resultsThe primary endpoint was obtained in 10 of 14 patients enrolled in the sub-study. MSNA burst frequency and burst incidence decreased in 6 of 10 patients: mean change -4.1 bursts/min (95% confidence interval -12.2 to 4.0) and -3.8 bursts/100 heartbeats (-15.2 to 7.7). MSNA spike frequency and spike count decreased in 8 of 10 patients: mean change -2.8 spikes/sec (-7.3 to 1.8) and -3.0 spikes/heartbeat (-6.1 to 0.1). Change in MSNA and BP were not correlated. Office BP decreased by -14/-6 mmHg (-27 to -2/-15 to 3). We observed a trend towards decreased HR (-5 bpm, -10 to 1) and increased total power HRV (623 msec2, 78 to 1168). In contrast, BRS and cardiovascular responses remained unchanged after EVBA.

conclusionsIn this proof-of-principle study, EVBA did not significantly decrease MSNA in patients with resistant hypertension. EVBA did not impair baroreflex function.

trial registrationClinical trial registration at NCT02827032.

Indexed as

AdultBaroreflexEndovascular ProceduresFemaleHumansHypertensionMaleMiddle AgedProof of Concept StudySympathetic Nervous SystemTreatment Outcome

Identifiers

PMID34784359
PMCPMC8594823
OpenAlexW3211694766

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.