Surgical Removal of Carotid Body in Patients With Systolic Heart Failure

Systolic Heart Failure Clinical Trial

— FIM  

Official title:

Surgical Removal of Carotid Body in Patients With Systolic Heart Failure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653821
• Other study ID #: FIM-WROCPL-CORIDEA
• Status: Completed
• Phase: N/A
• First received: July 26, 2012
• Last updated: October 14, 2016
• Start date: August 2012
• Est. completion date: November 2013

Study information

• Verified date: October 2016
• Source: Noblewell
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to determine safety, tolerability and feasibility of unilateral and bilateral carotid body excision in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Severe sleep apnea syndrome diagnosed in PSG

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Hypersensitivity
• Peripheral Chemoreceptor Hypersensitivity
• Systolic Heart Failure

Intervention

Procedure:
• Carotid body excision

Locations

Country	Name	City	State
Poland	Centrum Choro´b Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Noblewell

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral chemosensitivity	Ventilatory response to hypoxia using transient inhalation of nitrogen.	4 weeks	No

External Links

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