Clinical trial NCT01362725: Spinal Cord Stimulation For Heart Failure
Official title: Spinal Cord Stimulation For Heart Failure As A Restorative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Systolic Heart Failure
Keywords: spinal cord stimulation
systolic heart failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this feasibility study are to determine the safety of spinal cord stimulation (SCS) as a therapy in patients with systolic heart failure and to gather observational information for potential efficacy markers

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

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. These changes that occur due to SCS are shown to be effective in reducing the symptoms of chronic angina and pain secondary to peripheral vascular disease where both situations are characterized by decreased blood flow and inflammation.

The SCS system consists of an implantable pulse generator(IPG) and lead(s). 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 further benefit patients with heart failure (HF).

Eligibility criteria: Inclusion Criteria:

* Patients has a LVEF between 20% and 35%
* Patient is in NYHA Class III or in Ambulatory Class IV
* Patient has had a SJM implantable cardioverter defibrillator (ICD) device or a SJM CRT-D device implanted \>90 days and is receiving stable medical therapy for HF (\>90 days) at Baseline
* Patient has a LV end diastolic diameter between 55mm and 80mm
* 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 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 (AF)
* 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, INR \>1.2 and platelet count \<100 x109 per liter)
* Patient has a local infection at the 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 18 years old
* Patient's life's expectancy is less than 1 year as assessed by investigators

Primary outcomes:
measure: Safety and efficacy markers
timeFrame: 6 months
Secondary outcomes:
measure: long-term safety
timeFrame: 24 months
Other outcomes:
Locations:
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Tokyo
country: Japan
facility: University of Tokyo Hospital
Study officials:
affiliation: The University of Hong Kong, Queen Mary Hospital
name: Hung-Fat Tse, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Armour JA, Linderoth B, Arora RC, DeJongste MJ, Ardell JL, Kingma JG Jr, Hill M, Foreman RD. Long-term modulation of the intrinsic cardiac nervous system by spinal cord neurons in normal and ischaemic hearts. Auton Neurosci. 2002 Jan 10;95(1-2):71-9. doi: 10.1016/s1566-0702(01)00377-0.
citation: Deer TR, Raso LJ. Spinal cord stimulation for refractory angina pectoris and peripheral vascular disease. Pain Physician. 2006 Oct;9(4):347-52.
citation: Mannheimer C, Carlsson CA, Emanuelsson H, Vedin A, Waagstein F, Wilhelmsson C. The effects of transcutaneous electrical nerve stimulation in patients with severe angina pectoris. Circulation. 1985 Feb;71(2):308-16. doi: 10.1161/01.cir.71.2.308.
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.