Neurostimulation of Spinal Nerves That Affect the Heart
Summary
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.
Description
Protocol Summary
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Chronic Heart Failure
Intervention
Neurostimulation, Standard of Care Therapy
Location
Methodist Hospital
Houston
Texas
United States
77030
Status
Not yet recruiting
Source
The Methodist Hospital System
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01124136
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.
Cardiomegaly
Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES.
Kidney Failure
A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.
Cardiomyopathy, Alcoholic
Disease of CARDIAC MUSCLE resulting from chronic excessive alcohol consumption. Myocardial damage can be caused by: (1) a toxic effect of alcohol; (2) malnutrition in alcoholics such as THIAMINE DEFICIENCY; or (3) toxic effect of additives in alcoholic beverages such as COBALT. This disease is usually manifested by DYSPNEA and palpitations with CARDIOMEGALY and congestive heart failure (HEART FAILURE).
Equipment Failure
Failure of equipment to perform to standard. The failure may be due to defects or improper use.
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