Surgical Removal of Carotid Body in Patients With Systolic Heart Failure

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01653821

Acronym

FIM

Enrollment

Registered

2012-07-31

Start date

2012-08-31

Completion date

2013-11-30

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Chemoreceptor Hypersensitivity, Systolic Heart Failure

Keywords

carotid body, heart failure, chemoreceptor, hypersensitivity

Brief 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.

Interventions

PROCEDURECarotid body excision

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Peripheral chemosensitivity	4 weeks	Ventilatory response to hypoxia using transient inhalation of nitrogen.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026