A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function

Study Overview
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Brief Summary
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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
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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
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Heart Failure, Systolic Dysfunction

Intervention / Treatment
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* Device: Spinal cord stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Spinal cord stimulation on top of standard treatment | Device: Spinal cord stimulation<br> <br> |
| No Intervention: Control<br>Standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline, 30, 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline, 30, 60 days | 
| 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 | Tilt-test, Valsalva maneuver, deep breath test | Baseline, 30, 60 days | 
| Levels of pro-inflammatory plasma markers | TNF-a, CRP, fibrinogen | Baseline, 30, 60 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord stimulation, heart failure, autonomic regulation, BNP, left ventricle systolic dysfunction