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

This study is currently recruiting participants.
Verified January 2013 by Noblewell
Sponsor:
Collaborator:
Cibiem, Inc.
Information provided by (Responsible Party):
Noblewell
ClinicalTrials.gov Identifier:
NCT01653821
First received: July 26, 2012
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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.


Estimated Enrollment: 15
Study Start Date: August 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653821

Contacts
Contact: Piotr Ponikowski, Prof. +48717660279
Contact: Piotr Niewinski, Dr

Locations
Poland
Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny Recruiting
Wroclaw, Poland, 50-981
Contact: Piotr Niewinski, Dr     +48717660230        
Principal Investigator: Piotr Ponikowski, Prof.            
Sponsors and Collaborators
Noblewell
Cibiem, Inc.
  More Information

No publications provided

Responsible Party: Noblewell
ClinicalTrials.gov Identifier: NCT01653821     History of Changes
Other Study ID Numbers: FIM-WROCPL-CORIDEA
Study First Received: July 26, 2012
Last Updated: January 21, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Noblewell:
carotid body
heart failure
chemoreceptor
hypersensitivity

Additional relevant MeSH terms:
Heart Failure
Hypersensitivity
Heart Failure, Systolic
 Heart Diseases
Cardiovascular Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013