Heart FailureRAPID-HELPNCT02450110
A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function
A study testing Spinal cord stimulation in people with Heart Failure and Systolic Dysfunction, 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
A randomized pilot study of spinal cord stimulation in patients with chronic heart failure aiming to show whether this therapy impacts central haemodynamic and autonomic regulations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure, Systolic Dysfunction
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2015to Sep 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic heart failure II-III class (NYHA);
- Age 18-70 years;
- Left ventricle ejection fraction ≤35%;
- Optimal heart failure management according to the guidelines;
- Signed informed consent
Who cannot join
- Heart transplant list;
- Acute conditions, including systemic infection;
- Reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc);
- Planned elective heart surgery or intervention;
- Recent (3 months) myocardial infarction, coronary intervention;
- Heart failure decompensation;
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- Implanted cardiac resynchronization device < 6 months ago;
- Contraindications for lumbal puncture or placement of a spinal cord pacing electrode;
- Permanent atrial fibrillation;
- Stroke or TIA < 6 months ago;
- Pulmonary thromboembolist < 3 months ago;
- Hypertrophic cardiomyopathy with obstruction;
- Angina III-IV class, or congestive heart failure IV class;
- Participation in any other clinical trial;
- Women of childbearing possibility without appropriate contraception, pregnant, or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal North-West Medical Research Centre
Saint Petersburg, 197341
About this study
A randomized pilot study of spinal cord stimulation in patients with chronic heart failure aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.
Read the detailed description
Patients will be randomized (1:1) for spinal cord stimulation as an addition to optimal guidelines-driven management or to control group on optimal management only. Spinal cord stimulation will be performed for 30 days, and outcome measures will be testes before stimulation, after 30 days stimulation and after 30 days of further follow-up. The control group will be studied at baseline and after 30 days only.
- Conditions
- Heart Failure, Systolic Dysfunction
- Being tested
- Spinal cord stimulation
- Keywords
- spinal cord stimulation, heart failure, autonomic regulation, BNP, left ventricle systolic dysfunction
- 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 stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Spinal cord stimulation on top of standard treatment Receives: Device: Spinal cord stimulation |
| Control | No intervention | Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics of NT-pro-BNP-level
NT-pro-BNP-level baseline, 30 days and 60 days (intervention) NT-pro-BNP-level baseline, 30 days (control)
Measured: Baseline, 30, 60 days
Secondary outcomes (9)
Exercise capacity as determined by a cardiopulmonary test
Exercise capacity (cardiopulmonary test) baseline, 30 days and 60 days (intervention) Exercise capacity (cardiopulmonary test) baseline, 30 days (control)
Measured: Baseline, 30, 60 days
Changes in heart failure functional class
Measured: Baseline, 30, 60 days
Changes in atrial effective refractory period
Measured: Baseline, 30, 60 days
Number of participants with ventricular arrhythmias
Measured: Baseline, 30, 60 days
Autonomic regulation tests results change
Tilt-test, Valsalva maneuver, deep breath test
Measured: Baseline, 30, 60 days
Levels of pro-inflammatory plasma markers
TNF-a, CRP, fibrinogen
Measured: Baseline, 30, 60 days
Changes in left ventricle ejection fraction as determined by echocardiography
Measured: Baseline, 30, 60 days
Left ventricle volume
Measured: Baseline, 30, 60 days
Number of participants with complications
Measured: Baseline, 30, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: unexpectedly slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 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 V Shlyakhto, MD, DSc, Principal investigator, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450110
- Sponsor's protocol ID
- RAPID-HELP
- Acronym
- RAPID-HELP
- Status last verified
- Feb 2020
- First submitted
- 12 May 2015
- Last updated
- 13 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function
- ClinicalTrials.gov ID
- NCT02450110
- Acronym / sponsor ID
- RAPID-HELP / RAPID-HELP
- Conditions
- Heart Failure, Systolic Dysfunction
- Keywords
- spinal cord stimulation, heart failure, autonomic regulation, BNP, left ventricle systolic dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unexpectedly slow recruitment rate
- Enrolment
- 3 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
- Feb 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 21 May 2015 (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.
A randomized pilot study of spinal cord stimulation in patients with chronic heart failure aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.
Detailed description
Patients will be randomized (1:1) for spinal cord stimulation as an addition to optimal guidelines-driven management or to control group on optimal management only. Spinal cord stimulation will be performed for 30 days, and outcome measures will be testes before stimulation, after 30 days stimulation and after 30 days of further follow-up. The control group will be studied at baseline and after 30 days only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Spinal cord stimulationSpinal cord stimulation on top of standard treatment |
| Control | No intervention | –Standard treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic heart failure II-III class (NYHA);
- Age 18-70 years;
- Left ventricle ejection fraction ≤35%;
- Optimal heart failure management according to the guidelines;
- Signed informed consent
Key exclusion criteria (15 listed)
- Heart transplant list;
- Acute conditions, including systemic infection;
- Reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc);
- Planned elective heart surgery or intervention;
- Recent (3 months) myocardial infarction, coronary intervention;
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 stimulation | Device | Intervention |
Primary outcome
Dynamics of NT-pro-BNP-level
Time frame: Baseline, 30, 60 days
NT-pro-BNP-level baseline, 30 days and 60 days (intervention) NT-pro-BNP-level baseline, 30 days (control)
9 secondary outcomes
Exercise capacity as determined by a cardiopulmonary test
Time frame: Baseline, 30, 60 days
Changes in heart failure functional class
Time frame: Baseline, 30, 60 days
Changes in atrial effective refractory period
Time frame: Baseline, 30, 60 days
Number of participants with ventricular arrhythmias
Time frame: Baseline, 30, 60 days
Autonomic regulation tests results change
Time frame: Baseline, 30, 60 days
Levels of pro-inflammatory plasma markers
Time frame: Baseline, 30, 60 days
Changes in left ventricle ejection fraction as determined by echocardiography
Time frame: Baseline, 30, 60 days
Left ventricle volume
Time frame: Baseline, 30, 60 days
Number of participants with complications
Time frame: Baseline, 30, 60 days
Results and safety
The study was stopped early (reason given: unexpectedly slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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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 V Shlyakhto, MD, DSc principal investigator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
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 and Systolic Dysfunction, 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 5 inclusion and 15 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 13 Feb 2020. 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: unexpectedly slow recruitment rate). 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?
Dynamics of NT-pro-BNP-level (time frame: Baseline, 30, 60 days). 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 13 Feb 2020.