Neurostimulation of Spinal Nerves That Affect the Heart
The purpose of this study is to study the use of neurostimulation in chronic advanced refractory heart failure.
The study is determine if it is safe to use neurostimulation in patients with chronic advanced refractory heart failure and to also determine initial observations with regards to its potential effect on heart function and quality of life. The investigators hypothesis is that this study will show both safe and positive effect of neurostimulation on heart failure patients.
Chronic Heart Failure
Other: Standard of Care Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Effect of Neurostimulation in Patients With Symptomatic Heart Failure|
- Markers of cardiovascular safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Markers of cardiovascular safety will include specific clinical events that define worsening of heart failure including hospitalization for worsening heart failure, symptomatic brady-arrhythmia or tachy-arrhythmia necessitating cardioversion or death.
- Markers of device-device interaction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Markers of device-device interaction will include failure to properly provide pacing or adequate defibrillation or inappropriate shocks. Also, failure to initiate neurostimluation as programmed by the protocol
- Markers of efficacy [ Time Frame: Average: till the end of the study ] [ Designated as safety issue: No ]Markers of efficacy will include change in left ventricular ejection fraction as determined by echocardiography, change in maximal oxygen consumption as measured by cardio-pulmonary exercise testing, and change in quality of life as measured by the MLHFQ. Other exploratory markers include measurements in diastolic function by echocardiography, changes in neurohormonal and inflammatory markers, specifically BNP, plasma cytokines(TNF alpha and IL 6), complement, and C-reactive protein.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Implantation of neurostimulator
Other Name: Neurostimulator
|Active Comparator: Control||
Other: Standard of Care Therapy
Standard of Care Therapy
Other Name: Standard Care
Title EVALUATION OF THE SAFETY OF NEUROSTIMULATION IN PATIENTS WITH SYMPTOMATIC HEART FAILURE FEASIBILTIY STUDY
Description A feasibility trial of the use of neurostimulation in chronic advanced refractory heart failure.
Objective To determine the safety of neurostimulation in patients with chronic advanced refractory heart failure and to generate initial observations with regards to its potential effect on ventricular function and quality of life.
Design The trial will be a randomized double blind crossover feasibility trial with 2 week and 1,2,3,4,5,6,7 month clinical follow-up.
After device implantation, patients enrolled in the trial will have been randomly assigned to have device programmed to deliver impulses, active, or to have the device programmed not to deliver impulses, inactive, for 3 months.
After the 3 month initial phase, the devices will be inactivated and a 4 week washout period will convene.
At the end of washout period, patients that were inactive during initial phase will crossover to active and similarly patients that were active during initial phase will crossover to inactive.
Patient Population Patients with non-ischemic or ischemic cardiomyopathy with a length of illness of at least 6 months who have met the inclusion and exclusion criteria.
Enrollment Enrollment of a total of 10 intent-to-treat patients Investigational Sites Up to 2 investigational sites in the US Data Collection Data collection will be obtained in three categories: markers of cardiovascular safety, markers of device-device interactions and markers of efficacy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124136
|United States, Texas|
|Houston, Texas, United States, 77030|
|Contact: Guillermo Torre, MD, PH.D 713-441-1100 GTorre@tmhs.org|
|Contact: Jerry Estep, MD 713-441-1100 JEstep@tmhs.org|
|Principal Investigator: Guillermo Torre, MD, PHD|
|Principal Investigator:||Guillermo Torre, MD, PHD||The Methodist Hospital System|