Back to resultsSurgical Removal of Carotid Body in Patients With Systolic Heart Failure (FIM)
Primary Purpose
Systolic Heart Failure, Peripheral Chemoreceptor Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Carotid body excision
Sponsored by
About this trial
This is an interventional treatment trial for Systolic Heart Failure focused on measuring carotid body, heart failure, chemoreceptor, hypersensitivity
Eligibility 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
Sites / Locations
- Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Carotid body excision
Arm Description
Patients undergoing unilateral or bilateral removal of carotid body.
Outcomes
Primary Outcome Measures
Peripheral chemosensitivity
Ventilatory response to hypoxia using transient inhalation of nitrogen.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01653821
Brief Title
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure
Acronym
FIM
Official Title
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noblewell
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic Heart Failure, Peripheral Chemoreceptor Hypersensitivity
Keywords
carotid body, heart failure, chemoreceptor, hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carotid body excision
Arm Type
Experimental
Arm Description
Patients undergoing unilateral or bilateral removal of carotid body.
Intervention Type
Procedure
Intervention Name(s)
Carotid body excision
Primary Outcome Measure Information:
Title
Peripheral chemosensitivity
Description
Ventilatory response to hypoxia using transient inhalation of nitrogen.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23541331
Citation
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.
Results Reference
derived
Learn more about this trial
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure
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