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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Federal North-West Medical Research Centre
Saint Petersburg, Russia
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)
Time frame: Baseline, 30, 60 days
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)
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
Tilt-test, Valsalva maneuver, deep breath test
Time frame: Baseline, 30, 60 days
Levels of pro-inflammatory plasma markers
TNF-a, CRP, fibrinogen
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
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Number of participants with complications
Time frame: Baseline, 30, 60 days