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

Primary Purpose

Systolic Heart Failure, Peripheral Chemoreceptor Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Bilateral Surgical Resection of Carotid Bodies
Sponsored by
Noblewell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systolic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bilateral Surgical Resection of Carotid Bodies

Arm Description

Patients undergoing Bilateral Surgical Resection of Carotid Bodies.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Quality of life
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks.
Serum concentration of NT-proBNP
Change from baseline in serum concentration of NT-proBNP at 4 weeks.
Barosensitivity
Change from baseline in barosensitivity at 4 weeks.
Peripheral chemosensitivity
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks.
Muscle sympathetic nerve activity
Change from baseline in muscle sympathetic nerve activity at 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.
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.
Quality of life
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks.
Heart function and morphology
Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks.
Serum concentration of NT-proBNP
Change from baseline in serum concentration of NT-proBNP at 8 weeks.
Barosensitivity
Change from baseline in barosensitivity at 8 weeks.
Arrhythmia burden
Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks.

Full Information

First Posted
January 31, 2013
Last Updated
October 14, 2016
Sponsor
Noblewell
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1. Study Identification

Unique Protocol Identification Number
NCT01782677
Brief Title
Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure
Official Title
Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noblewell

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic Heart Failure, Peripheral Chemoreceptor Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral Surgical Resection of Carotid Bodies
Arm Type
Experimental
Arm Description
Patients undergoing Bilateral Surgical Resection of Carotid Bodies.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Surgical Resection of Carotid Bodies
Primary Outcome Measure Information:
Title
Peripheral chemosensitivity
Description
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.
Time Frame
4 weeks
Title
Muscle sympathetic nerve activity
Description
Change from baseline in muscle sympathetic nerve activity at 4 weeks.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Exercise tolerance
Description
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.
Time Frame
4 weeks
Title
Quality of life
Description
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks.
Time Frame
4 weeks
Title
Serum concentration of NT-proBNP
Description
Change from baseline in serum concentration of NT-proBNP at 4 weeks.
Time Frame
4 weeks
Title
Barosensitivity
Description
Change from baseline in barosensitivity at 4 weeks.
Time Frame
4 weeks
Title
Peripheral chemosensitivity
Description
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks.
Time Frame
8 weeks
Title
Muscle sympathetic nerve activity
Description
Change from baseline in muscle sympathetic nerve activity at 8 weeks.
Time Frame
8 weeks
Title
Exercise tolerance
Description
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.
Time Frame
8 weeks
Title
Sleep pattern in PSG
Description
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.
Time Frame
8 weeks
Title
Quality of life
Description
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks.
Time Frame
8 weeks
Title
Heart function and morphology
Description
Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks.
Time Frame
8 weeks
Title
Serum concentration of NT-proBNP
Description
Change from baseline in serum concentration of NT-proBNP at 8 weeks.
Time Frame
8 weeks
Title
Barosensitivity
Description
Change from baseline in barosensitivity at 8 weeks.
Time Frame
8 weeks
Title
Arrhythmia burden
Description
Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Ponikowski, Prof.
Organizational Affiliation
4. Wojskowy Szpital Kliniczny we Wroclawiu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland

12. IPD Sharing Statement

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

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