Clinical trial NCT02450110: A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Systolic Dysfunction
Keywords: spinal cord stimulation
heart failure
autonomic regulation
BNP
left ventricle systolic dysfunction
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dynamics of NT-pro-BNP-level
timeFrame: Baseline, 30, 60 days
Secondary outcomes:
measure: Exercise capacity as determined by a cardiopulmonary test
timeFrame: Baseline, 30, 60 days
measure: Changes in heart failure functional class
timeFrame: Baseline, 30, 60 days
measure: Changes in atrial effective refractory period
timeFrame: Baseline, 30, 60 days
measure: Number of participants with ventricular arrhythmias
timeFrame: Baseline, 30, 60 days
measure: Autonomic regulation tests results change
timeFrame: Baseline, 30, 60 days
measure: Levels of pro-inflammatory plasma markers
timeFrame: Baseline, 30, 60 days
measure: Changes in left ventricle ejection fraction as determined by echocardiography
timeFrame: Baseline, 30, 60 days
measure: Left ventricle volume
timeFrame: Baseline, 30, 60 days
measure: Number of participants with complications
timeFrame: Baseline, 30, 60 days
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Federal North-West Medical Research Centre
Study officials:
affiliation: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
name: Evgeny V Shlyakhto, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References: