Clinical trial NCT01782677: Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure
Official title: Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systolic Heart Failure
Peripheral Chemoreceptor Hypersensitivity
Lead sponsor: Noblewell
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Peripheral chemosensitivity
timeFrame: 4 weeks
measure: Muscle sympathetic nerve activity
timeFrame: 4 weeks
Secondary outcomes:
measure: Exercise tolerance
timeFrame: 4 weeks
measure: Quality of life
timeFrame: 4 weeks
measure: Serum concentration of NT-proBNP
timeFrame: 4 weeks
measure: Barosensitivity
timeFrame: 4 weeks
measure: Peripheral chemosensitivity
timeFrame: 8 weeks
measure: Muscle sympathetic nerve activity
timeFrame: 8 weeks
measure: Exercise tolerance
timeFrame: 8 weeks
measure: Sleep pattern in PSG
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 8 weeks
measure: Heart function and morphology
timeFrame: 8 weeks
measure: Serum concentration of NT-proBNP
timeFrame: 8 weeks
measure: Barosensitivity
timeFrame: 8 weeks
measure: Arrhythmia burden
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
Study officials:
affiliation: 4. Wojskowy Szpital Kliniczny we Wroclawiu
name: Piotr Ponikowski, Prof.
role: PRINCIPAL_INVESTIGATOR
References: