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

This study has been completed.
Sponsor:
Collaborator:
Cibiem, Inc.
Information provided by (Responsible Party):
Noblewell
ClinicalTrials.gov Identifier:
NCT01653821
First received: July 26, 2012
Last updated: November 22, 2013
Last verified: November 2013

July 26, 2012
November 22, 2013
August 2012
November 2013   (final data collection date for primary outcome measure)
Peripheral chemosensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Ventilatory response to hypoxia using transient inhalation of nitrogen.
Same as current
Complete list of historical versions of study NCT01653821 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure.

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Systolic Heart Failure
  • Peripheral Chemoreceptor Hypersensitivity
Procedure: Carotid body excision
Experimental: Carotid body excision
Patients undergoing unilateral or bilateral removal of carotid body.
Intervention: Procedure: Carotid body excision
Niewiński 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 PMID: 23541331.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01653821
FIM-WROCPL-CORIDEA
No
Noblewell
Noblewell
Cibiem, Inc.
Not Provided
Noblewell
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP