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

Sponsor

Noblewell (Industry)

Overall Status

Completed

CT.gov ID

NCT01653821

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Systolic Heart Failure Peripheral Chemoreceptor Hypersensitivity	Procedure: Carotid body excision	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

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.

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carotid body excision Patients undergoing unilateral or bilateral removal of carotid body.	Procedure: Carotid body excision

Arm

Intervention/Treatment

Experimental: Carotid body excision

Patients undergoing unilateral or bilateral removal of carotid body.

Procedure: Carotid body excision

Outcome Measures

Primary Outcome Measures

Peripheral chemosensitivity [4 weeks]
Ventilatory response to hypoxia using transient inhalation of nitrogen.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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