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

• Sponsor: Noblewell (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01782677
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Systolic Heart Failure; Peripheral Chemoreceptor Hypersensitivity	Procedure: Bilateral Surgical Resection of Carotid Bodies	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bilateral Surgical Resection of Carotid Bodies Patients undergoing Bilateral Surgical Resection of Carotid Bodies.	Procedure: Bilateral Surgical Resection of Carotid Bodies

Outcome Measures

Primary Outcome Measures

1. Peripheral chemosensitivity [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 [4 weeks]

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

Secondary Outcome Measures

1. Exercise tolerance [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 [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 [4 weeks]

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

4. Barosensitivity [4 weeks]

   Change from baseline in barosensitivity at 4 weeks.

5. Peripheral chemosensitivity [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 [8 weeks]

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

7. Exercise tolerance [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 [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 [8 weeks]

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

10. Heart function and morphology [8 weeks]

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

11. Serum concentration of NT-proBNP [8 weeks]

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

12. Barosensitivity [8 weeks]

    Change from baseline in barosensitivity at 8 weeks.

13. Arrhythmia burden [8 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny	Wroclaw		Poland	50-981

Sponsors and Collaborators

• Noblewell

Investigators

• Principal Investigator: Piotr Ponikowski, Prof., 4. Wojskowy Szpital Kliniczny we Wroclawiu

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Noblewell
• ClinicalTrials.gov Identifier: NCT01782677
• Other Study ID Numbers: FIM-B
• First Posted: Feb 4, 2013
• Last Update Posted: Oct 18, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Heart Failure; Heart Failure, Systolic; Hypersensitivity; Systolic Murmurs

Study Results

No Results Posted as of Oct 18, 2016