NCT01653821CompletedNot Applicable
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure.
Noblewell2 sites in 1 country10 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Peripheral chemosensitivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Peripheral chemosensitivity
Time Frame: 4 weeks
Ventilatory response to hypoxia using transient inhalation of nitrogen.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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