Neurostimulation of Spinal Nerves That Affect the Heart - Full Text View

Sponsor:	The Methodist Hospital System
Information provided by:	The Methodist Hospital System
ClinicalTrials.gov Identifier:	NCT01124136

Purpose

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.

Condition	Intervention	Phase
Chronic Heart Failure	Device: Neurostimulation Other: Standard of Care Therapy	Phase 1

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:

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.

Estimated Enrollment:	10
Study Start Date:	May 2010
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Neurostimulation	Device: Neurostimulation Implantation of neurostimulator Other Name: Neurostimulator
Active Comparator: Control	Other: Standard of Care Therapy Standard of Care Therapy Other Name: Standard Care

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female ≥18 years
Chronic heart failure (HF) NYHA class III-IV (ischemic and non-ischemic)
LVEF ≤ 30% at baseline by echocardiography
6 minute walk test score of less than 450 meters at baseline
Hospitalization for HF or IV administration of inotropic agents, human B-natriuretic peptide or IV diuretics ( in past 12 months and stable x 2 weeks)
On std medical therapy for CHF
No changes in cardiac medications 1 week prior to treatment;
Written informed consent.

Exclusion Criteria:

Inability to comply with the conditions of the protocol;
Presence of a transplanted tissue or organ or LVAD (or planned within the next 12 months)
Planned AICD or CRT within the next 12 months unless AICD is prescribed for primary prevention
Pacemaker dependent patients.
Acute MI, CABG, PTCA, within the past 3 months
Chronic refractory angina or peripheral vascular pain
Valvular heart disease requiring repair or replacement
Need for chronic intermittent inotropic therapy;
Malignancy: evidence of disease within the previous 5 years
Known HIV infection or immunodeficiency state
Chronic active viral infection (i.e., hepatitis B/C)
Severe systemic infection (undergoing treatment with antibiotics)
Active myocarditis or early postpartum cardiomyopathy (within the first 6-months of delivery)
Systemic corticosteroids, cytostatics and immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), DNA depleting or cytotoxic drugs taken within 4 weeks prior to study treatment;
Patient is pregnant, of childbearing potential and not using adequate contraceptive methods, or nursing.
Patient scheduled for hospice care;
Any other medical, social or geographical factor, which would make it unlikely that the patient will comply with study procedures (eg. Alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location and a history of non-compliance).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124136

Locations

United States, Texas
Methodist Hospital	Recruiting
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

Sponsors and Collaborators

The Methodist Hospital System

Investigators

Principal Investigator:

Guillermo Torre, MD, PHD

The Methodist Hospital System

More Information

No publications provided

Responsible Party:	Guillermo Torre, M.D., The Methodist Hospital System
ClinicalTrials.gov Identifier:	NCT01124136 History of Changes
Other Study ID Numbers:	0708-0211
Study First Received:	May 10, 2010
Last Updated:	May 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by The Methodist Hospital System:

Chronic Heart Failure
Neurostimulation

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012