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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Noblewell
Sponsor:
Collaborator:
Cibiem, Inc.
Information provided by (Responsible Party):
Noblewell
ClinicalTrials.gov Identifier:
NCT01782677
First received: January 31, 2013
Last updated: August 28, 2013
Last verified: August 2013
  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:


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: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 28, 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 July 29, 2014