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Systolic Heart FailurePhase 2/3SCS HEARTNCT01362725

Spinal Cord Stimulation For Heart Failure

A Phase 2/3 study testing Spinal cord stimulation system in people with Systolic Heart Failure, run by Abbott Medical Devices at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Systolic Heart Failure
What is being tested?
Spinal cord stimulation system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesin 3 countries
Study dates
Apr 2011to Jan 2016
Phase
Phase 2/3
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 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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, 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

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Australia2 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

Other trials in Australia

Japan2 sites

  • Osaka University Hospital

    Osaka

  • University of Tokyo Hospital

    Tokyo

Other trials in Japan

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Spinal Cord Stimulation For Heart Failure As A Restorative Treatment

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

Read the 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).

Being tested
Spinal cord stimulation system
Keywords
spinal cord stimulation, systolic heart failure
Medical subject headings
Heart Failure, Systolic

What participants receive

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

  • Spinal cord stimulation systemDevice

    Also called Eon Mini Neurostimulation System,, Octrode® percutaneous lead (Model 3186),, Eon Mini IPG (Model 3788),, Eon Patient ProgrammerTM (Model 3851),

    An implantable pulse generator (IPG) will deliver low-intensity electrical pulses which travel from the IPG through the leads to the electrodes positioned at the selected nerve fibers to provide the therapeutic stimulation.

Study groups in NCT01362725
Study groupRoleWhat they receive
Spinal cord stimulationExperimentalNot described
Receives: Device: Spinal cord stimulation system

What is being measured

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

  1. Safety and efficacy markers

    Intra and post procedure adverse events, exercise and functional capacity, left ventricular structure and function, inflammatory condition, and quality of life.

    Measured: 6 months

Secondary outcomes (1)

  1. long-term safety

    post procedural adverse 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 posted30 May 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionAug 2014
  4. Study completionJan 2016

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01362725
Sponsor's protocol ID
CI-10-029-ID-SC
Acronym
SCS HEART
Status last verified
Jan 2019
First submitted
26 May 2011
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • 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.

    PubMed 11873770

  • Deer TR, Raso LJ. Spinal cord stimulation for refractory angina pectoris and peripheral vascular disease. Pain Physician. 2006 Oct;9(4):347-52.

    PubMed 17066119

  • 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.

    PubMed 3871177

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Spinal cord stimulation system in people with Systolic Heart Failure, run by Abbott Medical Devices at 5 sites in 3 countries.

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: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia, Japan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and 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 NCT01362725, which also lists 6 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 4 Feb 2019.

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