Systolic Heart FailureFIMNCT01653821
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure
A study testing Carotid body excision in people with Systolic Heart Failure and Peripheral Chemoreceptor Hypersensitivity, run by Noblewell at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Heart Failure, Peripheral Chemoreceptor Hypersensitivity
- What is being tested?
- Carotid body excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
Wroclaw, 50-981
About this study
Official title: Surgical Removal of Carotid Body in Patients With Systolic Heart Failure.
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.
- Being tested
- Carotid body excision
- Keywords
- carotid body, heart failure, chemoreceptor, hypersensitivity
- Medical subject headings
- Heart Failure, Systolic, Heart Failure, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid body excisionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Carotid body excision | Experimental | Patients undergoing unilateral or bilateral removal of carotid body. Receives: Procedure: Carotid body excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral chemosensitivity
Ventilatory response to hypoxia using transient inhalation of nitrogen.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noblewell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653821
- Sponsor's protocol ID
- FIM-WROCPL-CORIDEA
- Acronym
- FIM
- Status last verified
- Oct 2016
- First submitted
- 26 Jul 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23541331
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Removal of Carotid Body in Patients With Systolic Heart Failure.
- ClinicalTrials.gov ID
- NCT01653821
- Acronym / sponsor ID
- FIM / FIM-WROCPL-CORIDEA
- Keywords
- carotid body, heart failure, chemoreceptor, hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NoblewellIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid body excision | Experimental | Procedure: Carotid body excisionPatients undergoing unilateral or bilateral removal of carotid body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid body excision | Procedure or surgery | Carotid body excision |
Primary outcome
Peripheral chemosensitivity
Time frame: 4 weeks
Ventilatory response to hypoxia using transient inhalation of nitrogen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Derived from this study: PubMed 23541331Niewinski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid body excision in people with Systolic Heart Failure and Peripheral Chemoreceptor Hypersensitivity, run by Noblewell at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral chemosensitivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01653821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.