Clinical trial NCT01112579: Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
Official title: Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.


Eligibility criteria: Inclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) of 35 percent or less
* New York Heart Association (NYHA) functional Class III at time of screening
* QRS duration less than 120 milliseconds (ms)
* Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months
* Receiving stable optimal medical therapy for heart failure prior to enrollment
* Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL)
* 18 years of age or older
* Willing and able to comply with study procedures
* Expected lifespan greater than 12 months beyond study enrollment as assessed by physician

Exclusion Criteria:

* Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician
* Polyneuropathy
* Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
* Unable to perform an exercise capacity test
* Pregnant or planning to become pregnant during this study
* Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study
* Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days
* Had a heart transplant
* Has complete heart block
* Had Acute Coronary Syndrome within the past 90 days
* Has congenital heart disease with significant hemodynamic shunting
* Has chemotherapy-induced heart failure
* Has reversible cardiomyopathy
* Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area)
* Has diagnosed unstable angina pectoris
* Has unstable coronary artery disease
* Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy
* Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead
* Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater
* Has an existing neurostimulator

Primary outcomes:
measure: Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months
timeFrame: Baseline and 6 Months
measure: Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months
timeFrame: Baseline and 6 Months
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Allentown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Burlington
country: United States
state: Vermont
city: Spokane
country: United States
state: Washington
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Prague
country: Czech Republic
city: Berlin
country: Germany
city: Herne
country: Germany
city: Rome
country: Italy
city: Groningen
country: Netherlands
city: Maastricht
country: Netherlands
city: Zwolle
country: Netherlands
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: Gothenburg
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Krannert Institute of Cardiology
name: Douglas P Zipes, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite Universitatsmedizin Berlin - Campus Charite Mitte
name: Heinz Theres, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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 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.