Heart FailureNCT01939912
Study on Reflex Response During Temporary Stimulation and Inhibition of Chemoreceptors of Carotid Bodies - a Pilot Study
A study testing Adenosine in people with Heart Failure and Peripheral Chemoreceptor Hypersensitivity, run by Noblewell at 1 site in Poland.
Trial summary
The isolated response of the carotid bodies to local stimulation with adenosine has not been researched in humans. There are single reports indicating that intravenous administration of adenosine causes hyperventilation through activating the carotid bodies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Peripheral Chemoreceptor Hypersensitivity
- What is being tested?
- Adenosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2013to Sep 2016
- 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
- stenosis of one of the internal carotid arteries qualifying the patient to the procedure treatment (according to the ESC 2011 or American Heart Association (AHA) guidelines) or the necessity of the carotid artery arteriography, in order to verify the level of narrowing;
- in the case of procedure treatment, patient's declaration to be treated by the percutaneous method;
- stable clinical condition for at least 4 weeks prior to the inclusion in the study;
- over 18 years of age;
- ability to give and giving the informed consent to participate in the study.
Who cannot join
- bilateral significant carotid artery stenosis;
- complete closure or critical constriction of either of the carotid arteries;
- brain stroke or transient ischaemic attack (TIA) within 6 months prior to the inclusion in the study;
- unstable angina pectoris, coronary attack within 3 months prior to the inclusion in the study;
- coronary revascularisation or clinically significant infection within 1 month prior to the inclusion in the study;
- significant chronic neurological condition in medical history;
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- dipyridamole or theophyline-based medications taken by the patient;
- bronchial asthma;
- GOLD 3 or 4 Chronic Obstructive Pulmonary Disease (COPD) in medical history;
- second or third degree atrioventricular block, sick sinus syndrome, or an additional evident track of atrioventricular conducting;
- advanced first degree atrioventricular block (PQ > 240 ms)
- extension of the QTc interval > 0.5 s;
- grade 3 (ESC) arterial hypertension;
- previously stated oversensitivity to adenosine;
- pregnancy;
- patients undergoing haemodialysis or peritoneal dialysis at inclusion in the study;
- undergone heart transplantation;
- any significant, in the investigator's assessment, aberrations detected in additional tests, increasing the risk related to performing procedures predicted by the protocol;
- lack of informed consent for the participation in the study;
- stage III (Fontaine) obliterative arteriosclerosis of the lower limb and/or Buerger's disease.
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 isolated response of the carotid bodies to local stimulation with adenosine has not been researched in humans. There are single reports indicating that intravenous administration of adenosine causes hyperventilation through activating the carotid bodies.
Adenosine will be injected intraarterially during invasive treatment (percutaneous carotid artery stenting, CAS) or diagnostic (arteriography) procedures and their conduct will only slightly influence the standard scheme of the procedure.
- Being tested
- Adenosine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Antiarrhythmic agent.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation of carotid body chemoreceptors | Experimental | Adenosine boluses will be administered through an intravascular catheter used to administer the contrast agent during the carotid artery arteriography. Receives: Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation at rest
Assessment of the adenosine influence on the monitored parameter
Measured: 30 minutes
Arterial blood pressure
Assessment of the adenosine influence on the monitored parameter
Measured: 30 minutes
Secondary outcomes (3)
ECG
Assessment of the adenosine influence on the monitored parameter
Measured: 30 minutes
Capillary blood saturation
Assessment of the adenosine influence on the monitored parameter
Measured: 30 minutes
Breathing pattern
Assessment of the adenosine influence on the monitored parameter
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2016
- Study completionSep 2016
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 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)
- Collaborators
- Cibiem, Inc.
- Responsible party
- Sponsor
- Investigators
- Piotr Ponikowski, Prof., Principal investigator, 4. Wojskowy Szpital Kliniczny we Wroclawiu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939912
- Sponsor's protocol ID
- ADENOSINE-PILOT-CIBIEM
- Status last verified
- Oct 2016
- First submitted
- 29 Aug 2013
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tubek S, Niewinski P, Reczuch K, Janczak D, Rucinski A, Paleczny B, Engelman ZJ, Banasiak W, Paton JF, Ponikowski P. Effects of selective carotid body stimulation with adenosine in conscious humans. J Physiol. 2016 Nov 1;594(21):6225-6240. doi: 10.1113/JP272109. Epub 2016 Sep 11.
PubMed 27435894
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Reflex Response During Temporary Stimulation and Inhibition of Chemoreceptors of Carotid Bodies - a Pilot Study
- ClinicalTrials.gov ID
- NCT01939912
- Acronym / sponsor ID
- ADENOSINE-PILOT-CIBIEM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NoblewellIndustry (pharma, biotech, devices)
- Collaborators
- Cibiem, Inc.
- Study start
- Aug 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Sep 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 isolated response of the carotid bodies to local stimulation with adenosine has not been researched in humans. There are single reports indicating that intravenous administration of adenosine causes hyperventilation through activating the carotid bodies.
Adenosine will be injected intraarterially during invasive treatment (percutaneous carotid artery stenting, CAS) or diagnostic (arteriography) procedures and their conduct will only slightly influence the standard scheme of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation of carotid body chemoreceptors | Experimental | Drug: AdenosineAdenosine boluses will be administered through an intravascular catheter used to administer the contrast agent during the carotid artery arteriography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stenosis of one of the internal carotid arteries qualifying the patient to the procedure treatment (according to the ESC 2011 or American Heart Association (AHA) guidelines) or the necessity of the carotid artery arteriography, in order to verify the level of narrowing;
- in the case of procedure treatment, patient's declaration to be treated by the percutaneous method;
- stable clinical condition for at least 4 weeks prior to the inclusion in the study;
- over 18 years of age;
- ability to give and giving the informed consent to participate in the study.
Key exclusion criteria (20 listed)
- bilateral significant carotid artery stenosis;
- complete closure or critical constriction of either of the carotid arteries;
- brain stroke or transient ischaemic attack (TIA) within 6 months prior to the inclusion in the study;
- unstable angina pectoris, coronary attack within 3 months prior to the inclusion in the study;
- coronary revascularisation or clinically significant infection within 1 month prior to the inclusion in the study;
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 |
|---|---|---|
| AdenosineAntiarrhythmic agent. | Drug | Stimulation of carotid body chemoreceptors |
Primary outcome
Ventilation at rest
Time frame: 30 minutes
Assessment of the adenosine influence on the monitored parameter
Arterial blood pressure
Time frame: 30 minutes
Assessment of the adenosine influence on the monitored parameter
3 secondary outcomes
ECG
Time frame: 30 minutes
Capillary blood saturation
Time frame: 30 minutes
Breathing pattern
Time frame: 30 minutes
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 17 Oct 2016.
- Derived from this study: PubMed 27435894Tubek S, Niewinski P, Reczuch K, Janczak D, Rucinski A, Paleczny B, Engelman ZJ, Banasiak W, Paton JF, Ponikowski P. Effects of selective carotid body stimulation with adenosine in conscious humans. J Physiol. 2016 Nov 1;594(21):6225-6240. doi: 10.1113/JP272109. Epub 2016 Sep 11.
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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 Adenosine in people with 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 5 inclusion and 20 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 17 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?
Ventilation at rest (time frame: 30 minutes). 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?
On the ClinicalTrials.gov record for NCT01939912, 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 17 Oct 2016.