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CompletedNCT01653821FIMUpdated Oct 18, 2016

Surgical Removal of Carotid Body in Patients With Systolic Heart Failure

An interventional study of Carotid body excision in Systolic Heart Failure and Peripheral Chemoreceptor Hypersensitivity, sponsored by Noblewell. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-18.

Sponsored by Noblewell · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to determine safety, tolerability and feasibility of unilateral and bilateral carotid body excision in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity.

02

Conditions studied

  • Systolic Heart Failure
  • Peripheral Chemoreceptor Hypersensitivity

Keywords

  • carotid body
  • heart failure
  • chemoreceptor
  • hypersensitivity
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 10 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Noblewell is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • History of heart failure class II-III according to NYHA within at least 6 months prior to inclusion
  • Stable clinical state within at least 4 weeks prior to inclusion
  • Subject >= 18 years old
  • Left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (Simpson's method)
  • Carotid body present in computer cervical angiotomography
  • History of exacerbated peripheral chemoreceptor sensitivity determined as >0.6L/min/%SpO2
  • Able and willing to give written informed consent

Exclusion criteria

Exclusion Criteria:

  • Unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to inclusion
  • History of stroke, transient ischemic attack (TIA), or clinically significant chronic neurological disorder
  • History of heart transplant
  • Pregnancy or anticipation of pregnancy
  • Hemodialysis or peritoneal dialysis patients
  • Obstructive carotid atherosclerotic disease with >50% stenosis
  • Severe sleep apnea syndrome diagnosed in PSG
  • COPD stage III and IV according to GOLD 2007
  • Unable to perform the spiroergometric assessment
  • Any significant anomaly in additional investigation which may increase the risk of study procedure
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Carotid body excision

    Patients undergoing unilateral or bilateral removal of carotid body.

    Procedure: Carotid body excision

Interventions

  • ProcedureCarotid body excision
06

What researchers measure

Primary outcomes

  1. Peripheral chemosensitivity

    Ventilatory response to hypoxia using transient inhalation of nitrogen.

    Time frame: 4 weeks

07

Study locations

1 site
  • Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
    Wroclaw, 50-981, Poland
08

References and documents

Publications

  • Niewinski P, Janczak D, Rucinski A, Jazwiec P, Sobotka PA, Engelman ZJ, Fudim M, Tubek S, Jankowska EA, Banasiak W, Hart EC, Paton JF, Ponikowski P. Carotid body removal for treatment of chronic systolic heart failure. Int J Cardiol. 2013 Oct 3;168(3):2506-9. doi: 10.1016/j.ijcard.2013.03.011. Epub 2013 Mar 29. PubMed 23541331 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01653821
Lead sponsor
Noblewell
Responsible party
Sponsor
First posted
Jul 31, 2012
Start date
Aug 2012
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Oct 18, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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