Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Systolic Heart Failure; Peripheral Chemoreceptor Hypersensitivity
• Intervention / Treatment: Procedure: Bilateral Surgical Resection of Carotid Bodies

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Wroclaw, Poland, 50-981
    • Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral Surgical Resection of Carotid Bodies; Patients undergoing Bilateral Surgical Resection of Carotid Bodies.	Procedure: Bilateral Surgical Resection of Carotid Bodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral chemosensitivity	Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.	4 weeks
Muscle sympathetic nerve activity	Change from baseline in muscle sympathetic nerve activity at 4 weeks.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise tolerance	Change from baseline in exercise tolerance (peak oxygen consumption, slope relating minute ventilation to carbon dioxide production, oxygen uptake efficiency slope, time of exercise, 6-minute walking test distance, New York Heart Association Class) at 4 weeks.	4 weeks
Quality of life	Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks.	4 weeks
Serum concentration of NT-proBNP	Change from baseline in serum concentration of NT-proBNP at 4 weeks.	4 weeks
Barosensitivity	Change from baseline in barosensitivity at 4 weeks.	4 weeks
Peripheral chemosensitivity	Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks.	8 weeks
Muscle sympathetic nerve activity	Change from baseline in muscle sympathetic nerve activity at 8 weeks.	8 weeks
Exercise tolerance	Change from baseline in exercise tolerance (peak oxygen consumption, slope relating minute ventilation to carbon dioxide production, oxygen uptake efficiency slope, time of exercise, 6-minute walking test, New York Heart Association Class) at 8 weeks.	8 weeks
Sleep pattern in PSG	Change from baseline in sleep pattern in PSG (apnoea-hypopnoea index, percentage of central and obstructive episodes, average oxygen saturation, number of arousals, average duration of apnoeic and hypopnoeic episodes) at 8 weeks.	8 weeks
Quality of life	Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks.	8 weeks
Heart function and morphology	Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks.	8 weeks
Serum concentration of NT-proBNP	Change from baseline in serum concentration of NT-proBNP at 8 weeks.	8 weeks
Barosensitivity	Change from baseline in barosensitivity at 8 weeks.	8 weeks
Arrhythmia burden	Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks.	8 weeks

Collaborators and Investigators

• Sponsor: Noblewell
• Investigators: Principal Investigator: Piotr Ponikowski, Prof., 4. Wojskowy Szpital Kliniczny we Wroclawiu

Publications and helpful links

Helpful Links

• Carotid body resection for sympathetic modulation in systolic heart failure: results from first-in-man study

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Immune System Diseases; Heart Murmurs; Heart Failure; Hypersensitivity; Systolic Murmurs; Heart Failure, Systolic
• Other Study ID Numbers: FIM-B