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

Systolic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782677
• Other study ID #: FIM-B
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: October 14, 2016
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2016
• Source: Noblewell
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Hypersensitivity
• Peripheral Chemoreceptor Hypersensitivity
• Systolic Heart Failure

Intervention

Procedure:
• Bilateral Surgical Resection of Carotid Bodies

Locations

Country	Name	City	State
Poland	Centrum Choro´b Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Noblewell

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral chemosensitivity	Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.	4 weeks	Yes
Primary	Muscle sympathetic nerve activity	Change from baseline in muscle sympathetic nerve activity at 4 weeks.	4 weeks	Yes
Secondary	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	No
Secondary	Quality of life	Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks.	4 weeks	No
Secondary	Serum concentration of NT-proBNP	Change from baseline in serum concentration of NT-proBNP at 4 weeks.	4 weeks	No
Secondary	Barosensitivity	Change from baseline in barosensitivity at 4 weeks.	4 weeks	No
Secondary	Peripheral chemosensitivity	Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks.	8 weeks	No
Secondary	Muscle sympathetic nerve activity	Change from baseline in muscle sympathetic nerve activity at 8 weeks.	8 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Quality of life	Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks.	8 weeks	No
Secondary	Heart function and morphology	Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks.	8 weeks	No
Secondary	Serum concentration of NT-proBNP	Change from baseline in serum concentration of NT-proBNP at 8 weeks.	8 weeks	No
Secondary	Barosensitivity	Change from baseline in barosensitivity at 8 weeks.	8 weeks	No
Secondary	Arrhythmia burden	Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks.	8 weeks	No

External Links

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