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

NCT01782677 | Completed DMC

• 1 other identifier: FIM-B
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Systolic Heart Failure; Peripheral Chemoreceptor Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• Peripheral chemosensitivity

  Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.

  4 weeks

• Muscle sympathetic nerve activity

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

  4 weeks

Secondary Outcomes (13)

• Exercise tolerance

  4 weeks

• Quality of life

  4 weeks

• Serum concentration of NT-proBNP

  4 weeks

• Barosensitivity

  4 weeks

• Peripheral chemosensitivity

  8 weeks

Study Arms (1)

Bilateral Surgical Resection of Carotid Bodies

EXPERIMENTAL

Patients undergoing Bilateral Surgical Resection of Carotid Bodies.

Procedure: Bilateral Surgical Resection of Carotid Bodies

Interventions

Bilateral Surgical Resection of Carotid Bodies PROCEDURE

Bilateral Surgical Resection of Carotid Bodies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Noblewell: lead

Study Sites (1)

Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny

Wroclaw, 50-981, Poland

Location

Related Links

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

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Piotr Ponikowski, Prof.

  4. Wojskowy Szpital Kliniczny we Wroclawiu

  PRINCIPAL INVESTIGATOR

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: January 31, 2013
• First Posted: February 4, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

PL (1)