To evaluate whether spinal cord stimulation is benificial for chronic heart failure patients
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences between the treatment group and the control group regarding:
• Reduction of the left ventricle after 6 months of spinal cord stimulation (as
measured with echo: LVESVi)
Secondary outcome
Treatment group vs control group diferences in:
• Biomarkers from blood sampling (e.g. ProBNP, BNP, cathecholamines, BUN,
creatinine)
• Maximal oxygen uptake
• Quality of life
Background summary
Congestive heart failure is a syndrome associated with symptoms caused by
impaired ventricular function. An abnormal neuro-hormonal activation is
responsible for further progression of disease. For the last decade, the
primary treatment for heart failure has been through pharmacologic blockade of
this abnormal neuro-hormonal activation through the use of beta-blockers and
ACE inhibitors. Despite improvements in treatment, the prognosis for patients
with heart failure remains poor; the risk of death annually is 5-10% in
patients with mild symptoms and 30-40% in those with more advanced disease.
More recently, Cardiac Resynchronisation Therapy (CRT) has been shown to
provide further morbidity and mortality benefits in addition to pharmacologic
therapy in patients with ventricular dyssynchrony (wide QRS) and a reduced left
ventricular ejection fraction <= 35%. CRT is currently the only approved device
therapy proven to reduce mortality, improve quality of life, and reverse
myocardial remodeling in patients with symptomatic heart failure. CRT, however,
is currently limited to patients with EF<35%, class III/IV HF, and a wide QRS.
Approximately 75% of heart failure patients are not indicated for CRT, leaving
many patients in need of new HF therapies that improve morbidity and mortality.
Study objective
To evaluate whether spinal cord stimulation is benificial for chronic heart
failure patients
Study design
• Prospective, multicenter, international, parallel randomized to either
treatment group or control group (3:2)
• 250 patients, max 30 centers
• Treatment group: neurostimulator ON during the whole of the study
• Control group: neurostimulator OFF for first 6 months, after this
neurostimulator is switched ON
• Both study arms will receive a neurostimulator and already have optimal
medical therapy (and possibly an ICD)
• Follow up: baseline, implant/randomisation, 1 month post-implant, 3, 6, 7
(controls only), 9 month, 12 month, exit visits (2 week, 4 week)
(see flowchart p9). If the patient wishes to continue the study after 12
months, an extra yearly follow-up will be added until study end.
• Expected study duration for the patient is minimally 12 months and maximally
48 months
Intervention
• Implantation of a neurostimulator (1-3 hours)
• Neurostimulation of the spinal cord (12 hours/day)
• Quality of Life questionnaires
Study burden and risks
BURDEN/RISKS
• Risks that are associated with the implantation of a neurostimulator (p37,
p48)
• An MRI scan with a neurostimulator in place is not recommended
• Spinal cord stimulation may cause odd sensations
• Extra testing in hospital is time-consuming for the patient
BENEFITS
Spinal cord stimulation:
• may cause improvements in cardiac function and exercise capacity
• may be a new therapy, also for other patients that are not indicated for
Cardiac resynchronisation Therapy (CRT)
• Extra testing in the hospital may lead to more tailored treatment for this
patient group
Earl Bakkenstraat 10
6422 PJ Heerlen
NL
Earl Bakkenstraat 10
6422 PJ Heerlen
NL
Listed location countries
Age
Inclusion criteria
• LVEF of 35% or less
• NYHA functional Class III
• QRS duration less than 120 ms
• LVEDD of 55 mm - 80 mm
• Receiving stable medical therapy for heart failure prior to enrollment.
(see p15)
Exclusion criteria
• Temporal stop of anticoagulation therapy poses an unacceptable health risk
• Inability to perform an exercise capacity test
• Pregnancy or likely to get pregant during the course of the study
• CABG/PCI/BMS procedures within the past 90 days
• Heart transplant
• Acute Coronary Syndrome within the past 90 days
• Congenital heart disease with significant hemodynamic shunting
• Reversible cardiomyopathy (i.e. tachycardia induced heart failure)
• Diagnosed unstable angina pectoris
• Unstable coronary artery disease
• CRT device implanted
• non-Medtronic ICD, pacemaker or defibrillation lead
• Patient already has a neurostimulator
(see p15-16)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01112579 |
| CCMO | NL34381.042.10 |