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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01653821
First Posted: July 31, 2012
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Noblewell
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653821


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Noblewell
ClinicalTrials.gov Identifier: NCT01653821     History of Changes
Other Study ID Numbers: FIM-WROCPL-CORIDEA
First Submitted: July 26, 2012
First Posted: July 31, 2012
Last Update Posted: October 18, 2016
Last Verified: October 2016

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