Surgical Removal of Carotid Body in Patients With Systolic Heart Failure (FIM)

This study has been completed.
Cibiem, Inc.
Information provided by (Responsible Party):
Noblewell Identifier:
First received: July 26, 2012
Last updated: March 27, 2015
Last verified: March 2015
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.

Condition Intervention
Systolic Heart Failure
Peripheral Chemoreceptor Hypersensitivity
Procedure: Carotid body excision

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Removal of Carotid Body in Patients With Systolic Heart Failure.

Resource links provided by NLM:

Further study details as provided by Noblewell:

Primary Outcome Measures:
  • Peripheral chemosensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Ventilatory response to hypoxia using transient inhalation of nitrogen.

Enrollment: 10
Study Start Date: August 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carotid body excision
Patients undergoing unilateral or bilateral removal of carotid body.
Procedure: Carotid body excision


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • 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
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Please refer to this study by its identifier: NCT01653821

Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
Wroclaw, Poland, 50-981
Sponsors and Collaborators
Cibiem, Inc.
  More Information

No publications provided by Noblewell

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Noblewell Identifier: NCT01653821     History of Changes
Other Study ID Numbers: FIM-WROCPL-CORIDEA 
Study First Received: July 26, 2012
Last Updated: March 27, 2015
Health Authority: Poland: Ethics Committee

Keywords provided by Noblewell:
carotid body
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Cardiovascular Diseases
Heart Diseases
Immune System Diseases processed this record on February 11, 2016