Heart Failure, Systolic Dysfunction
Conditions
Keywords
spinal cord stimulation, heart failure, autonomic regulation, BNP, left ventricle systolic dysfunction
Brief 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.
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.
Interventions
DEVICESpinal cord stimulation
Sponsors
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with chronic heart failure II-III class (NYHA); 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
1. Heart transplant list; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamics of NT-pro-BNP-level | Baseline, 30, 60 days | NT-pro-BNP-level baseline, 30 days and 60 days (intervention) NT-pro-BNP-level baseline, 30 days (control) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in heart failure functional class | Baseline, 30, 60 days | — |
| Changes in atrial effective refractory period | Baseline, 30, 60 days | — |
| Number of participants with ventricular arrhythmias | Baseline, 30, 60 days | — |
| Autonomic regulation tests results change | Baseline, 30, 60 days | Tilt-test, Valsalva maneuver, deep breath test |
| Exercise capacity as determined by a cardiopulmonary test | Baseline, 30, 60 days | Exercise capacity (cardiopulmonary test) baseline, 30 days and 60 days (intervention) Exercise capacity (cardiopulmonary test) baseline, 30 days (control) |
| Changes in left ventricle ejection fraction as determined by echocardiography | Baseline, 30, 60 days | — |
| Left ventricle volume | Baseline, 30, 60 days | — |
| Number of participants with complications | Baseline, 30, 60 days | — |
| Levels of pro-inflammatory plasma markers | Baseline, 30, 60 days | TNF-a, CRP, fibrinogen |
Countries
Russia
Outcome results
None listed