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Completed

NCT Number: NCT01782677

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.

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Key information

Conditions

Systolic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Systolic Peripheral Chemoreceptor Hypersensitivity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wroclaw, 50-981, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral Surgical Resection of Carotid Bodies

Procedure

Primary outcomes

  1. Peripheral chemosensitivity

    Time frame: 4 weeks

    Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.

  2. Muscle sympathetic nerve activity

    Time frame: 4 weeks

    Change from baseline in muscle sympathetic nerve activity at 4 weeks.

Secondary outcomes

  1. Exercise tolerance

    Time frame: 4 weeks

    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.

  2. Quality of life

    Time frame: 4 weeks

    Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks.

  3. Serum concentration of NT-proBNP

    Time frame: 4 weeks

    Change from baseline in serum concentration of NT-proBNP at 4 weeks.

  4. Barosensitivity

    Time frame: 4 weeks

    Change from baseline in barosensitivity at 4 weeks.

  5. Peripheral chemosensitivity

    Time frame: 8 weeks

    Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks.

  6. Muscle sympathetic nerve activity

    Time frame: 8 weeks

    Change from baseline in muscle sympathetic nerve activity at 8 weeks.

  7. Exercise tolerance

    Time frame: 8 weeks

    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. Sleep pattern in PSG

    Time frame: 8 weeks

    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.

  9. Quality of life

    Time frame: 8 weeks

    Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks.

  10. Heart function and morphology

    Time frame: 8 weeks

    Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks.

  11. Serum concentration of NT-proBNP

    Time frame: 8 weeks

    Change from baseline in serum concentration of NT-proBNP at 8 weeks.

  12. Barosensitivity

    Time frame: 8 weeks

    Change from baseline in barosensitivity at 8 weeks.

  13. Arrhythmia burden

    Time frame: 8 weeks

    Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks.

Sponsors and collaborators

Lead sponsor

Noblewell

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2013
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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