Surgical Removal of Carotid Body in Patients With Systolic Heart Failure
FIM
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedOctober 18, 2016
October 1, 2016
1.3 years
July 26, 2012
October 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peripheral chemosensitivity
Ventilatory response to hypoxia using transient inhalation of nitrogen.
4 weeks
Study Arms (1)
Carotid body excision
EXPERIMENTALPatients undergoing unilateral or bilateral removal of carotid body.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Noblewelllead
Study Sites (1)
Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
Wroclaw, 50-981, Poland
Related Publications (1)
Niewinski P, Janczak D, Rucinski A, Jazwiec P, Sobotka PA, Engelman ZJ, Fudim M, Tubek S, Jankowska EA, Banasiak W, Hart EC, Paton JF, Ponikowski P. Carotid body removal for treatment of chronic systolic heart failure. Int J Cardiol. 2013 Oct 3;168(3):2506-9. doi: 10.1016/j.ijcard.2013.03.011. Epub 2013 Mar 29.
PMID: 23541331DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2012
First Posted
July 31, 2012
Study Start
August 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
October 18, 2016
Record last verified: 2016-10