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Heart FailureNCT03060148

Spinal Cord Stimulation in Heart Failure

A study testing Medtronic neurostimulation system in people with Heart Failure, run by Chang Gung Memorial Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 100 years
Conditions the study is for
Heart Failure
What is being tested?
Medtronic neurostimulation system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Jun 2017to Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Chun-Li Wang, MD contact

+886975368158

wang3015@cgmh.org.tw

About this study

Official title: The Treatment of Spinal Cord Stimulation in Severe Heart Failure

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).

Read the 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.

Conditions
Heart Failure
Being tested
Medtronic neurostimulation system
Keywords
Heart failure, Spinal cord stimulation
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic neurostimulation systemDevice

    Also called Medtronic Restore Sensor™ 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

Study groups in NCT03060148
Study groupRoleWhat they receive
Spinal cord stimulationActive comparatorMedtronic neurostimulation system for spinal cord stimulation
Receives: Device: Medtronic neurostimulation system
ControlNo interventionNo implantation of Medtronic neurostimulation system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (1)

  1. Post procedural adverse events

    Post-procedure adverse events include implanted procedure related events, system related events and system modification related events.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study startJun 2017 (estimated)
  3. Primary completionDec 2018 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Medtronic neurostimulation
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03060148
Sponsor's protocol ID
CMRPG3G0011
Status last verified
Mar 2017
First submitted
17 Feb 2017
Last updated
9 Jun 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 26682789

  • 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.

    PubMed 25500165

  • 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.

    PubMed 19597055

  • 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.

    PubMed 10946073

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic neurostimulation system in people with Heart Failure, run by Chang Gung Memorial Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chun-Li Wang, MD (+886975368158, wang3015@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of efficacy markers (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03060148, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.

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