A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function
NCT ID: NCT02450110
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2015-02-28
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Spinal cord stimulation on top of standard treatment
Spinal cord stimulation
Control
Standard treatment
No interventions assigned to this group
Interventions
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Spinal cord stimulation
Eligibility Criteria
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Inclusion Criteria
2. Age 18-70 years;
3. Left ventricle ejection fraction ≤35%;
4. Optimal heart failure management according to the guidelines;
5. Signed informed consent
Exclusion Criteria
2. Acute conditions, including systemic infection;
3. Reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc);
4. Planned elective heart surgery or intervention;
5. Recent (3 months) myocardial infarction, coronary intervention;
6. Heart failure decompensation;
7. Implanted cardiac resynchronization device \< 6 months ago;
8. Contraindications for lumbal puncture or placement of a spinal cord pacing electrode;
9. Permanent atrial fibrillation;
10. Stroke or TIA \< 6 months ago;
11. Pulmonary thromboembolist \< 3 months ago;
12. Hypertrophic cardiomyopathy with obstruction;
13. Angina III-IV class, or congestive heart failure IV class;
14. Participation in any other clinical trial;
15. Women of childbearing possibility without appropriate contraception, pregnant, or breastfeeding women.
18 Years
70 Years
ALL
No
Sponsors
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
OTHER
Responsible Party
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Principal Investigators
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Evgeny V Shlyakhto, MD, DSc
Role: PRINCIPAL_INVESTIGATOR
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Locations
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Federal North-West Medical Research Centre
Saint Petersburg, , Russia
Countries
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Other Identifiers
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RAPID-HELP
Identifier Type: -
Identifier Source: org_study_id
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