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Clinical Trials/NCT01653821
NCT01653821
Completed
Not Applicable

Surgical Removal of Carotid Body in Patients With Systolic Heart Failure.

Noblewell1 site in 1 country10 target enrollmentAugust 2012
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ConditionsSystolic Heart FailurePeripheral Chemoreceptor Hypersensitivity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systolic Heart Failure
Sponsor
Noblewell
Enrollment
10
Locations
1
Primary Endpoint
Peripheral chemosensitivity
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
November 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Noblewell
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Peripheral chemosensitivity

Time Frame: 4 weeks

Ventilatory response to hypoxia using transient inhalation of nitrogen.

Study Sites (1)

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