Systolic Heart FailureNCT01782677
Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure
A study testing Bilateral Surgical Resection of Carotid Bodies in people with Systolic Heart Failure and Peripheral Chemoreceptor Hypersensitivity, run by Noblewell at 1 site in Poland.
Trial 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. 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?
- Bilateral Surgical Resection of Carotid Bodies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2012to Dec 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
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- 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
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.
- Being tested
- Bilateral Surgical Resection of Carotid Bodies
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Surgical Resection of Carotid BodiesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Surgical Resection of Carotid Bodies | Experimental | Patients undergoing Bilateral Surgical Resection of Carotid Bodies. Receives: Procedure: Bilateral Surgical Resection of Carotid Bodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral chemosensitivity
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.
Measured: 4 weeks
Muscle sympathetic nerve activity
Change from baseline in muscle sympathetic nerve activity at 4 weeks.
Measured: 4 weeks
Secondary outcomes (13)
Exercise tolerance
Change from baseline in exercise tolerance (peak oxygen consumption, slope relating minute ventilation to carbon dioxide production, oxygen uptake efficiency slope, time of exercise, 6-minute walking test distance, New York Heart Association Class) at 4 weeks.
Measured: 4 weeks
Quality of life
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 4 weeks.
Measured: 4 weeks
Serum concentration of NT-proBNP
Change from baseline in serum concentration of NT-proBNP at 4 weeks.
Measured: 4 weeks
Barosensitivity
Change from baseline in barosensitivity at 4 weeks.
Measured: 4 weeks
Peripheral chemosensitivity
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 8 weeks.
Measured: 8 weeks
Muscle sympathetic nerve activity
Change from baseline in muscle sympathetic nerve activity at 8 weeks.
Measured: 8 weeks
Exercise tolerance
Change from baseline in exercise tolerance (peak oxygen consumption, slope relating minute ventilation to carbon dioxide production, oxygen uptake efficiency slope, time of exercise, 6-minute walking test, New York Heart Association Class) at 8 weeks.
Measured: 8 weeks
Sleep pattern in PSG
Change from baseline in sleep pattern in PSG (apnoea-hypopnoea index, percentage of central and obstructive episodes, average oxygen saturation, number of arousals, average duration of apnoeic and hypopnoeic episodes) at 8 weeks.
Measured: 8 weeks
Quality of life
Change from baseline in quality of life (Kansas City Cardiomyopathy Questionnaire, visual analog scale) at 8 weeks.
Measured: 8 weeks
Heart function and morphology
Change from baseline in heart function and morphology (transthoracic echocardiography) at 8 weeks.
Measured: 8 weeks
Serum concentration of NT-proBNP
Change from baseline in serum concentration of NT-proBNP at 8 weeks.
Measured: 8 weeks
Barosensitivity
Change from baseline in barosensitivity at 8 weeks.
Measured: 8 weeks
Arrhythmia burden
Change from baseline in arrhythmia burden (24 hour ECG tape) at 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noblewell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piotr Ponikowski, Prof., Principal investigator, 4. Wojskowy Szpital Kliniczny we Wroclawiu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782677
- Sponsor's protocol ID
- FIM-B
- Status last verified
- Oct 2016
- First submitted
- 31 Jan 2013
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
- Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure
- ClinicalTrials.gov ID
- NCT01782677
- Acronym / sponsor ID
- FIM-B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NoblewellIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Feb 2013 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral Surgical Resection of Carotid Bodies | Experimental | Procedure: Bilateral Surgical Resection of Carotid BodiesPatients undergoing Bilateral Surgical Resection of Carotid Bodies. |
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 (9 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 |
|---|---|---|
| Bilateral Surgical Resection of Carotid Bodies | Procedure or surgery | Bilateral Surgical Resection of Carotid Bodies |
Primary outcome
Peripheral chemosensitivity
Time frame: 4 weeks
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.
Muscle sympathetic nerve activity
Time frame: 4 weeks
Change from baseline in muscle sympathetic nerve activity at 4 weeks.
13 secondary outcomes
Exercise tolerance
Time frame: 4 weeks
Quality of life
Time frame: 4 weeks
Serum concentration of NT-proBNP
Time frame: 4 weeks
Barosensitivity
Time frame: 4 weeks
Peripheral chemosensitivity
Time frame: 8 weeks
Muscle sympathetic nerve activity
Time frame: 8 weeks
Exercise tolerance
Time frame: 8 weeks
Sleep pattern in PSG
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
Heart function and morphology
Time frame: 8 weeks
Serum concentration of NT-proBNP
Time frame: 8 weeks
Barosensitivity
Time frame: 8 weeks
Arrhythmia burden
Time frame: 8 weeks
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.
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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.
Piotr Ponikowski, Prof. principal investigator
4. Wojskowy Szpital Kliniczny we Wroclawiu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Surgical Resection of Carotid Bodies 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 9 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.