NCT01782677
Completed
Not Applicable
Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure
Noblewell1 site in 1 country5 target enrollmentDecember 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Systolic Heart Failure
- Sponsor
- Noblewell
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Muscle sympathetic nerve activity
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The primary aim of the study is to determine safety, tolerability and feasibility of bilateral carotid body resection in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of bilateral carotid body resection.
Investigators
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
- •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
Muscle sympathetic nerve activity
Time Frame: 4 weeks
Change from baseline in muscle sympathetic nerve activity at 4 weeks.
Peripheral chemosensitivity
Time Frame: 4 weeks
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.
Secondary Outcomes
- Heart function and morphology(8 weeks)
- Sleep pattern in PSG(8 weeks)
- Arrhythmia burden(8 weeks)
- Exercise tolerance(8 weeks)
- Quality of life(8 weeks)
- Serum concentration of NT-proBNP(8 weeks)
- Barosensitivity(8 weeks)
- Peripheral chemosensitivity(8 weeks)
- Muscle sympathetic nerve activity(8 weeks)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Surgical Removal of Carotid Body in Patients With Systolic Heart FailureSystolic Heart FailurePeripheral Chemoreceptor HypersensitivityNCT01653821Noblewell10
Completed
Not Applicable
" Endarterectomy Combined With Optimal Medical Therapy (OMT) vs OMT Alone in Patients With Asymptomatic Severe Atherosclerotic Carotid Artery Stenosis at Higher-than-average Risk of Ipsilateral Stroke "Asymptomatic Carotid Artery StenosisNCT02841098Centre Hospitalier St Anne43
Completed
Not Applicable
Carotid Body Removal for the Treatment of Resistant HypertensionHypertensionNCT01745172Noblewell4
Terminated
Phase 3
Carotid Occlusion Surgery StudyStrokeIschemic Attack, TransientCerebral InfarctionNCT00029146University of North Carolina, Chapel Hill700
Completed
Not Applicable
Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot StudyHypertensionNCT01729988Noblewell11