Spinal Cord Stimulation in Heart Failure

Heart Failure Clinical Trial

Official title:

The Treatment of Spinal Cord Stimulation in Severe Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03060148
• Other study ID #: CMRPG3G0011
• Status: Not yet recruiting
• Phase: N/A
• First received: February 17, 2017
• Last updated: June 7, 2017
• Start date: June 2017
• Est. completion date: June 2019

Study information

• Verified date: March 2017
• Source: Chang Gung Memorial Hospital
• Contact: Chun-Li Wang, MD
• Phone: +886975368158
• Email: wang3015[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Medtronic neurostimulation system
Dual leads for spinal cord stimulation will be performed at 90% of the motor threshold for 24 hours/day at 50 Hz and pulse width 0.2 ms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

References & Publications (4)

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. — View 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. — View Citation

Tse HF, Turner S, Sanders P, Okuyama Y, Fujiu K, Cheung CW, Russo M, Green MD, Yiu KH, Chen P, Shuto C, Lau EO, 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):588-95. doi: 10.1016/j.hrthm.2014.12.014. Epub 2014 Dec 12. — View 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 MJ; 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):129-36. doi: 10.1016/j.jchf.2015.10.006. Epub 2015 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of efficacy markers	Efficacy markers include peak oxygen uptake, New York Heart Association functional class, left ventricular structure and function (left ventricular end-systolic volume and ejection fraction), B-type natriuretic peptide, Minnesota Living with Heart Failure Questionnaire score: Improvement: +1; no change:0; worsening: -1.	6 months
Secondary	Post procedural adverse events	Post-procedure adverse events include implanted procedure related events, system related events and system modification related events.	24 months