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

Not Applicable

Terminated

• Conditions: Heart Failure; Systolic Dysfunction

• Registration Number: NCT02450110
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-21
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in heart failure functional class	Baseline, 30, 60 days
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)
Autonomic regulation tests results change	Baseline, 30, 60 days	Tilt-test, Valsalva maneuver, deep breath test
Levels of pro-inflammatory plasma markers	Baseline, 30, 60 days	TNF-a, CRP, fibrinogen
Number of participants with complications	Baseline, 30, 60 days
Changes in atrial effective refractory period	Baseline, 30, 60 days
Number of participants with ventricular arrhythmias	Baseline, 30, 60 days
Left ventricle volume	Baseline, 30, 60 days
Changes in left ventricle ejection fraction as determined by echocardiography	Baseline, 30, 60 days

Trial Locations

Locations (1)

Federal North-West Medical Research Centre; 🇷🇺 Saint-Petersburg, Russian Federation