Clinical trial NCT03060148: Spinal Cord Stimulation in Heart Failure
Official title: The Treatment of Spinal Cord Stimulation in Severe Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Spinal cord stimulation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Medtronic neurostimulation
Primary purpose: TREATMENT

Brief summary: Previous studies have shown that spinal cord stimulation (SCS) may improve cardiac output and decrease the risk of ischemic ventricular arrhythmia in animal model and its safety profile in human trial. The purposes of this study are to evaluate the feasibility, treatment efficacy and safety of SCS in patients with severe symptomatic heart failure (HF).

Detailed description: Morbidity and mortality in heart failure (HF) patients remain high, even with recent advances in therapies. Previous studies have shown that the autonomic nervous system plays an important role in the pathophysiology of HF and sudden cardiac death.

Spinal cord stimulation (SCS) is a neurostimulation therapy, which involves the stimulation of selected nerve fibers and intends to create end-organ responses characterized by changes in blood flow, decrease of catecholamines and reduction in inflammation. The SCS system consists of an implantable pulse generator (IPG) and dual leads. Each lead has electrodes on the distal end. Electrical impulses travel from the IPG through the leads to the electrodes positioned at the selected nerve fibers to provide the therapeutic stimulation. By virtue of its potential in augmenting blood flow, decreasing catecholamines and reducing inflammation, SCS may benefit HF patients.

Eligibility criteria: Inclusion Criteria:

* Patients has a left ventricular ejection fraction between 20% and 35%
* Patient is in New York Heart Association Class III or in Ambulatory Class IV
* Patient is receiving stable medical therapy for HF (\>90 days) at baseline
* Patient has a left ventricular end diastolic diameter between 55 mm and 80 mm
* Patient must be able and willing to provide written informed consent to participate in this study
* Patient must be able and willing to comply with the required follow-up schedule

Exclusion Criteria:

* Patient currently has an implanted spinal cord stimulator or previously had an implanted upper thoracic spinal cord stimulator which is now explanted
* Patient has polyneuropathy
* Patient requires short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy
* Patient has received a tissue/organ transplant (or is expected to have a tissue/organ transplant within the next 180 days)
* Patient has persistent or permanent atrial fibrillation
* Patient has chronic refractory angina or peripheral vascular pain
* Patient has critical valvular heart disease that requires valve repair or replacement
* Patient has had a myocardial infarction (MI) or cardiac revascularization procedure (percutaneous coronary intervention or coronary artery bypass graft) \<90 days at baseline or is expected to have this in the next 180 days
* Patient is on IV inotropic therapy
* Patient has active myocarditis or early postpartum cardiomyopathy
* Patient has taken any of the following drugs within 30 days of enrollment: systemic corticosteroids, cytostatic and immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), DNA depleting or cytotoxic drugs
* Patient is pregnant, or of childbearing potential and is not using adequate contraceptive methods, or nursing
* Patient with a bleeding tendency (International Normalized Ratio \>1.2 and platelet count \<100 x10\^9 per liter)
* Patient has a local infection at the implantable cardioverter-defibrillator (ICD) implant location or systemic infection
* Patient has renal insufficiency (creatinine \>3.0 mg/dl)
* Patient is participating in another clinical study
* Patient is less than 20 years old
* Patient's life's expectancy is less than 1 years as assessed by investigator

Primary outcomes:
measure: Composite of efficacy markers
timeFrame: 6 months
Secondary outcomes:
measure: Post procedural adverse events
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chun-Li Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zipes DP, Neuzil P, Theres H, Caraway D, Mann DL, Mannheimer C, Van Buren P, Linde C, Linderoth B, Kueffer F, Sarazin SA, DeJongste MJL; DEFEAT-HF Trial Investigators. Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Systolic Heart Failure: The DEFEAT-HF Study. JACC Heart Fail. 2016 Feb;4(2):129-136. doi: 10.1016/j.jchf.2015.10.006. Epub 2015 Dec 9.
citation: Tse HF, Turner S, Sanders P, Okuyama Y, Fujiu K, Cheung CW, Russo M, Green MDS, Yiu KH, Chen P, Shuto C, Lau EOY, Siu CW. Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): first-in-man experience. Heart Rhythm. 2015 Mar;12(3):588-595. doi: 10.1016/j.hrthm.2014.12.014. Epub 2014 Dec 12.
citation: Lopshire JC, Zhou X, Dusa C, Ueyama T, Rosenberger J, Courtney N, Ujhelyi M, Mullen T, Das M, Zipes DP. Spinal cord stimulation improves ventricular function and reduces ventricular arrhythmias in a canine postinfarction heart failure model. Circulation. 2009 Jul 28;120(4):286-94. doi: 10.1161/CIRCULATIONAHA.108.812412. Epub 2009 Jul 13.
citation: Foreman RD, Linderoth B, Ardell JL, Barron KW, Chandler MJ, Hull SS Jr, TerHorst GJ, DeJongste MJ, Armour JA. Modulation of intrinsic cardiac neurons by spinal cord stimulation: implications for its therapeutic use in angina pectoris. Cardiovasc Res. 2000 Aug;47(2):367-75. doi: 10.1016/s0008-6363(00)00095-x.