Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure - Full Text View

Purpose

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.

Condition	Intervention
Systolic Heart Failure Peripheral Chemoreceptor Hypersensitivity	Procedure: Bilateral Surgical Resection of Carotid Bodies

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Allergy Heart Failure

U.S. FDA Resources

Further study details as provided by Noblewell:

Primary Outcome Measures:

Peripheral chemosensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.
Muscle sympathetic nerve activity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in muscle sympathetic nerve activity at 4 weeks.

Secondary Outcome Measures:

Exercise tolerance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks.
Serum concentration of NT-proBNP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change from baseline in serum concentration of NT-proBNP at 4 weeks.
Barosensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change from baseline in barosensitivity at 4 weeks.
Peripheral chemosensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks.
Muscle sympathetic nerve activity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in muscle sympathetic nerve activity at 8 weeks.
Exercise tolerance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks.
Heart function and morphology [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks.
Serum concentration of NT-proBNP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in serum concentration of NT-proBNP at 8 weeks.
Barosensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in barosensitivity at 8 weeks.
Arrhythmia burden [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks.

Estimated Enrollment:	15
Study Start Date:	December 2012
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bilateral Surgical Resection of Carotid Bodies Patients undergoing Bilateral Surgical Resection of Carotid Bodies.	Procedure: Bilateral Surgical Resection of Carotid Bodies

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782677

Contacts

Contact: Piotr Ponikowski, Prof.

+48717660279

Locations

Poland
Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny	Recruiting
Wroclaw, Poland, 50-981
Contact: Piotr Ponikowski, Prof.
Contact: Piotr Niewinski, MD +48717660230

Sponsors and Collaborators

Noblewell

Cibiem, Inc.

Investigators

Principal Investigator:

Piotr Ponikowski, Prof.

4. Wojskowy Szpital Kliniczny we Wroclawiu

More Information

No publications provided

Responsible Party:	Noblewell
ClinicalTrials.gov Identifier:	NCT01782677 History of Changes
Other Study ID Numbers:	FIM-B
Study First Received:	January 31, 2013
Last Updated:	January 31, 2013
Health Authority:	Poland: Ethics Committee

Additional relevant MeSH terms:

Heart Failure
Hypersensitivity
Heart Failure, Systolic

Heart Diseases
Cardiovascular Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013