Cardiac InsufficiencyEpiCANSNCT05255952
Epicardial Stimulation of the Cardiac Autonomic Nervous System
A study testing Electrical stimulation in people with Cardiac Insufficiency, run by Rennes University Hospital at 1 site in France.
Trial summary
The objective of the EpiCANS study is to evaluate the technique of stimulation of the cardiac autonomic nervous system (SNAC) directly at the epicardial level in humans during heart surgery. Proof of concept study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Insufficiency
- What is being tested?
- Electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 16 Aug 2022to 13 Nov 2023
- 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
- Scheduled for elective cardiac surgery for valvular or coronary surgery
- Having received written and oral information about the protocol and having signed a written informed consent
- Affiliated or beneficiary of a social security plan
Who cannot join
- Patient with an indication for cardiac surgery:
- Urgent or semi-urgent
- Aortic surgery
- Heart transplantation
- Mechanical circulatory assistance
- Patients who have already undergone cardiac surgery
- Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors, persons unable to express their consent, persons hospitalized for a different reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EpiCANS : Epicardial Stimulation of the Cardiac Autonomic Nervous System
The objective of the EpiCANS study is to evaluate the technique of stimulation of the cardiac autonomic nervous system (SNAC) directly at the epicardial level in humans during heart surgery.
Proof of concept study
Read the detailed description
Isolated stimulation of the parasympathetic system induces a protective effect on long-term cardiac remodeling, but at the cost of inhibiting the sympathetic system. The role of the sympathetic system is to increase cardiac output in cases of acute heart failure.
Electrical stimulation of the cardiac plexus directly at the level of the heart allows simultaneous stimulation of the sympathetic and parasympathetic systems, whose complementary and not automatically antagonistic role is now recognized. Thus, direct stimulation of the plexus would optimize cardiac function in the short and long term by instantly improving cardiac output and decreasing pulmonary resistance as described in dogs by Kobayashi et al.
The objective of the EpiCANS study is to evaluate this technique in humans during cardiac surgery.
- Conditions
- Cardiac Insufficiency
- Being tested
- Electrical stimulation
- Keywords
- cardiac plexus, Electrical stimulation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationProcedure or surgery
Electrical stimulation of the cardiac plexus
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | 3 cycles of electrical stimualtions will be done at the end of cardiac surgery, before end of surgery (patient closure), under anaesthesia.
Cardiac outcomes will be monitored Receives: Procedure: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of cardiac output
Cardiac output (milliliter per minute) before and after stimulation
Measured: 15 min
Secondary outcomes (6)
Variation of Cardiac rythm
Heart rate (beat per minute) before and after stimulation
Measured: 15 min
Variation of aortic pressure
Aortic pressure (millimeter of mercury) before and after stimulation
Measured: 15 min
Variation of pulmonary artery pressure
Pulmonary artery pressure (millimeter of mercury) before and after stimulation
Measured: 15 min
Variation of central venous pressure
Central venous pressure (millimeter of mercury) before and after stimulation
Measured: 15 min
Presence of atrial fibrillation
Atrial fibrillation related to stimulation
Measured: 15 min
Adverses events
Advserse events during hospitalisation
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start16 Aug 2022
- Primary completion13 Oct 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac InsufficiencyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl BOU NADER, Dr, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255952
- Sponsor's protocol ID
- 35RC21_8946_04_EpiCANS
- Acronym
- EpiCANS
- Status last verified
- Sep 2024
- First submitted
- 15 Feb 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpiCANS : Epicardial Stimulation of the Cardiac Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT05255952
- Acronym / sponsor ID
- EpiCANS / 35RC21_8946_04_EpiCANS
- Conditions
- Cardiac Insufficiency
- Keywords
- cardiac plexus, Electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 25 Feb 2022 (actual)
- 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 objective of the EpiCANS study is to evaluate the technique of stimulation of the cardiac autonomic nervous system (SNAC) directly at the epicardial level in humans during heart surgery.
Proof of concept study
Detailed description
Isolated stimulation of the parasympathetic system induces a protective effect on long-term cardiac remodeling, but at the cost of inhibiting the sympathetic system. The role of the sympathetic system is to increase cardiac output in cases of acute heart failure.
Electrical stimulation of the cardiac plexus directly at the level of the heart allows simultaneous stimulation of the sympathetic and parasympathetic systems, whose complementary and not automatically antagonistic role is now recognized. Thus, direct stimulation of the plexus would optimize cardiac function in the short and long term by instantly improving cardiac output and decreasing pulmonary resistance as described in dogs by Kobayashi et al.
The objective of the EpiCANS study is to evaluate this technique in humans during cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Electrical stimulation3 cycles of electrical stimualtions will be done at the end of cardiac surgery, before end of surgery (patient closure), under anaesthesia. Cardiac outcomes will be monitored |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for elective cardiac surgery for valvular or coronary surgery
- Having received written and oral information about the protocol and having signed a written informed consent
- Affiliated or beneficiary of a social security plan
Key exclusion criteria (7 listed)
- Patient with an indication for cardiac surgery:
- Urgent or semi-urgent
- Aortic surgery
- Heart transplantation
- Mechanical circulatory assistance
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 |
|---|---|---|
| Electrical stimulationElectrical stimulation of the cardiac plexus | Procedure or surgery | Patients |
Primary outcome
Variation of cardiac output
Time frame: 15 min
Cardiac output (milliliter per minute) before and after stimulation
6 secondary outcomes
Variation of Cardiac rythm
Time frame: 15 min
Variation of aortic pressure
Time frame: 15 min
Variation of pulmonary artery pressure
Time frame: 15 min
Variation of central venous pressure
Time frame: 15 min
Presence of atrial fibrillation
Time frame: 15 min
Adverses events
Time frame: 10 days
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 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Karl BOU NADER, Dr study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation in people with Cardiac Insufficiency, run by Rennes University Hospital at 1 site in France.
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 3 inclusion and 7 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 27 Sep 2024. 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 France. 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?
Variation of cardiac output (time frame: 15 min). 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 27 Sep 2024.