Heart FailureNCT05288387
Spinal Cord Stimulation in Hypotensive Heart Failure Patients: Hemodynamic Assessment
A study testing Spinal cord stimulation in people with Heart Failure, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial summary
This is a prospective single-center study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation on systemic and pulmonary hemodynamics, assessed during right heart catheterization in patients with heart failure and persistent or transient hypotension subjected to be included into the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteRussia
- Study dates
- 25 Mar 2022to 9 Jan 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Patients with heart failure III-IV functional class (NYHA) with indications to right heart catheterization.
- Systolic blood pressure <110/70 mm Hg when measured while sitting.
- Patient who signed an informed consent form.
Who cannot join
- Hypovolemic status (central venous pressure <2 mm Hg).
- Any acute illness.
- Transient ischemic event or stroke within 2 weeks prior to inclusion.
- Pulmonary embolism <1 month ago.
- Epilepsy.
- An implanted infusion pump.
- Pacemaker-dependent patients.
- Patients who have contraindications to the use of the patch electrodes used in this study, as indicated in the respective instructions for use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Effects of Transcutaneous Spinal Cord Stimulation in Patients With Chronic Heart Failure Undergoing Right Heart Catheterization for the Inclusion Into the Heart Transplantation Program: a Pilot Study
This is a prospective single-center study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation on systemic and pulmonary hemodynamics, assessed during right heart catheterization in patients with heart failure and persistent or transient hypotension subjected to be included into the heart transplantation waiting list.
Read the detailed description
The study aims to assess hemodynamic effects of non-invasive transcutaneous spinal cord stimulation during invasive hemodynamics evaluation in patients with heart failure and transient or persistent hypotension undergoing catheterization before inclusion into the heart transplantation program. Eligible patients will sign an informed consent form before the procedure. Non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using high-frequency modulated electrical impulses through adhesive electrodes attached to the back skin. The stimulation protocol includes analysis of the following parameters: heart rate; electrocardiogram in 12 leads; invasive blood pressure; pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac input, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, pulmonary vascular resistance.
- Conditions
- Heart Failure
- Being tested
- Spinal cord 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.
Spinal cord stimulationProcedure or surgery
High-frequency stimulation with modulated current via skin patches captures posterior horns of the spinal cord and this activation leads to blood pressure elevation.
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord stimulation in heart failure patients with hypotension | Experimental | Adhesive patches are applied to subjects' back skin. Single stimuli are delivered in order to define the stimulation threshold under the guidance of neuromyography. Vascular access is performed (jugular or subclavian) according to conventional preparation to right heart catheterization. Invasive hemodynamic measures are performed as usual.
High-frequency spinal cord stimulation at T5 level is initiated, and repeated hemodynamic measures performed within 2 minutes. Stimulation lasts for 5-10 minutes, and then ceased. Following a 5-minutes waiting period, repeat hemodynamic measures are performed. The same sequence of steps applies for stimulation levels T7-8 and a combination of T5 and T7-8.
Then the procedure is completed and data are analysed. Receives: Procedure: Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure elevation
It is suggested that spinal cord stimulation will elevate averaged systolic blood pressure by >5 mmHg within 10 minutes, as compared to tilt testing without stimulation, and as measured invasively through a vascular catheter. Number of participants with increase in systolic blood pressure by more than 5 mmHg within 10 minutes will be counted. The achievement of the primary outcome will be considered if >50% of patients will have an increase in systolic blood pressure.
Measured: 10 minutes
Secondary outcomes (4)
Systemic vascular resistance elevation
It is suggested that spinal cord stimulation will elevate systemic vascular resistance by 10 percent (estimated using the standard equation method based on invasive hemodynamic measurements). Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated.
Measured: 10 minutes
Pulmonary vascular resistance change
A statistically detectable decrease in pulmonary vascular resistance in the patient group based on invasive hemodynamic measurements, and estimated using the standard equation method based on invasive hemodynamic measurements. Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated.
Measured: 10 minutes
Pulmonary capillary wedge pressure change
A statistically detectable change in pulmonary capillary wedge pressure in the patient group based on invasive measurements. Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated.
Measured: 10 minutes
Pulmonary artery pressure change
A statistically detectable change in pulmonary artery systolic, diastolic, or mean pressure in the patient group based on invasive measurements. Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start25 Mar 2022
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Why it stopped: No perceivable effect of transcutaneous spinal cord stimulation on blood pressure in heart failure patients
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evgeny N Mikhaylov, Assoc.prof., Principal investigator, Almazov National Medical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288387
- Sponsor's protocol ID
- HF-SCS-2022
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be discussed during regular meetings of the study and supervising committees after enrollment of at least 30% of subjects.
Publications
Mikhaylov EN, Moshonkina TR, Zharova EN, Garkina SV, Kovzelev PD, Belyaeva NN, Kozlenok AV, Lebedev DS, Shlyakhto EV. Acute Cardiovascular Effects of Non-Invasive Electrical Spinal Cord Stimulation: Results from a Pilot Study in Humans. J Cardiovasc Transl Res. 2020 Dec;13(6):891-893. doi: 10.1007/s12265-020-10014-7. Epub 2020 May 6.
PubMed 32378161
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Transcutaneous Spinal Cord Stimulation in Patients With Chronic Heart Failure Undergoing Right Heart Catheterization for the Inclusion Into the Heart Transplantation Program: a Pilot Study
- ClinicalTrials.gov ID
- NCT05288387
- Acronym / sponsor ID
- HF-SCS-2022
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No perceivable effect of transcutaneous spinal cord stimulation on blood pressure in heart failure patients
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 21 Mar 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.
This is a prospective single-center study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation on systemic and pulmonary hemodynamics, assessed during right heart catheterization in patients with heart failure and persistent or transient hypotension subjected to be included into the heart transplantation waiting list.
Detailed description
The study aims to assess hemodynamic effects of non-invasive transcutaneous spinal cord stimulation during invasive hemodynamics evaluation in patients with heart failure and transient or persistent hypotension undergoing catheterization before inclusion into the heart transplantation program. Eligible patients will sign an informed consent form before the procedure. Non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using high-frequency modulated electrical impulses through adhesive electrodes attached to the back skin. The stimulation protocol includes analysis of the following parameters: heart rate; electrocardiogram in 12 leads; invasive blood pressure; pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac input, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, pulmonary vascular resistance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord stimulation in heart failure patients with hypotension | Experimental | Procedure: Spinal cord stimulationAdhesive patches are applied to subjects' back skin. Single stimuli are delivered in order to define the stimulation threshold under the guidance of neuromyography. Vascular access is performed (jugular or subclavian) according to conventional preparation to right heart catheterization. Invasive hemodynamic measures are performed as usual. High-frequency spinal cord stimulation at T5 level is initiated, and repeated hemodynamic measures performed within 2 minutes. Stimulation lasts for 5-10 minutes, and then ceased. Following a 5-minutes waiting period, repeat hemodynamic measures are performed. The same sequence of steps applies for stimulation levels T7-8 and a combination of T5 and T7-8. Then the procedure is completed and data are analysed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years.
- Patients with heart failure III-IV functional class (NYHA) with indications to right heart catheterization.
- Systolic blood pressure <110/70 mm Hg when measured while sitting.
- Patient who signed an informed consent form.
Key exclusion criteria (8 listed)
- Hypovolemic status (central venous pressure <2 mm Hg).
- Any acute illness.
- Transient ischemic event or stroke within 2 weeks prior to inclusion.
- Pulmonary embolism <1 month ago.
- Epilepsy.
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 |
|---|---|---|
| Spinal cord stimulationHigh-frequency stimulation with modulated current via skin patches captures posterior horns of the spinal cord and this activation leads to blood pressure elevation. | Procedure or surgery | Spinal cord stimulation in heart failure patients with hypotension |
Primary outcome
Systolic blood pressure elevation
Time frame: 10 minutes
It is suggested that spinal cord stimulation will elevate averaged systolic blood pressure by >5 mmHg within 10 minutes, as compared to tilt testing without stimulation, and as measured invasively through a vascular catheter. Number of participants with increase in systolic blood pressure by more than 5 mmHg within 10 minutes will be counted. The achievement of the primary outcome will be considered if >50% of patients will have an increase in systolic blood pressure.
4 secondary outcomes
Systemic vascular resistance elevation
Time frame: 10 minutes
Pulmonary vascular resistance change
Time frame: 10 minutes
Pulmonary capillary wedge pressure change
Time frame: 10 minutes
Pulmonary artery pressure change
Time frame: 10 minutes
Results and safety
The study was stopped early (reason given: No perceivable effect of transcutaneous spinal cord stimulation on blood pressure in heart failure patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 32378161Mikhaylov EN, Moshonkina TR, Zharova EN, Garkina SV, Kovzelev PD, Belyaeva NN, Kozlenok AV, Lebedev DS, Shlyakhto EV. Acute Cardiovascular Effects of Non-Invasive Electrical Spinal Cord Stimulation: Results from a Pilot Study in Humans. J Cardiovasc Transl Res. 2020 Dec;13(6):891-893. doi: 10.1007/s12265-020-10014-7. Epub 2020 May 6.
- Individual participant dataSharing planned: No. Data sharing will be discussed during regular meetings of the study and supervising committees after enrollment of at least 30% of subjects.
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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.
Evgeny N Mikhaylov, Assoc.prof. principal investigator
Almazov National Medical Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation in people with Heart Failure, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 Mar 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 Russia. 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 was stopped early (reason given: No perceivable effect of transcutaneous spinal cord stimulation on blood pressure in heart failure patients). Results are not available in the source record.
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?
Systolic blood pressure elevation (time frame: 10 minutes). 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 NCT05288387, 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 6 Mar 2024.