Expired Study
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Houston, Texas 77030


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.


Study summary:

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.


Criteria:

Inclusion 1. Male or female ≥18 years; 2. Chronic heart failure NYHA class III-IV of ischemic and non-ischemic etiology; 3. Screening Left ventricular Ejection Fraction (LVEF) ≤ 30% measured at baseline by echocardiography; 4. Screening 6 minute walk test score of less than 450 meters measured at baseline; 5. Hospitalization for heart failure or outpatient IV administration of inotropic agents, human B-natriuretic peptide or IV diuretics within the past 12 months (stable for at least 2 weeks); 6. On standard optimal medical therapy for CHF before medical therapy.* 7. No changes in active cardiac medications during the 1 week prior to treatment; 8. Written informed consent. - Patients with current or prior symptoms of heart failure and reduced LVEF should be on stable optimally uptitrated medical therapy recommended according to current guidelines (Circulation. 2005; 112 (12): e154) as standard of care for heart failure therapy in the United States. This minimally includes an ACE-inhibitor (ACE-I) at stable doses for 1 month prior to enrollment, if tolerated, and a beta blocker (carvedilol, metoprolol succinate, or bisoprolol) for 3 months prior to enrollment, if tolerated, with a stable up-titrated dose for 1 month prior to enrollment. This also includes an Angiotensin II Receptor Blocker (ARB) at stable doses for 1 month prior to enrollment, if tolerated, when ACE-I is not tolerated. Stable is defined as no more than a 100% increase or a 50% decrease in dose. If the patient is intolerant to ACE-I, ARB, or beta blockers, documented evidence must be available. In those intolerant to both ACE-I and ARB, combination therapy with hydralazine and oral nitrate should be considered. Therapeutic equivalence for ACE-I substitutions is allowed within the enrollment stability timelines. Aldosterone inhibitor therapy should be added when NYHA Class III or IV symptoms occur on standard therapy. If aldosterone inhibitor therapy is administered in Class II patients, it must be initiated and optimized prior to enrollment. Eplerenone requires dosage stability for 1 month prior to enrollment. Diuretics may be used as necessary to keep the patient euvolemic. Exclusion 1. Inability to comply with the conditions of the protocol; 2. Inability to perform cardiopulmonary exercise test due to mechanical physical limitations 3. Presence of a transplanted tissue or organ or LVAD (or the expectation of the same within the next 12 months); 4. Planned AICD or CRT within the next 12 months unless AICD is prescribed for primary prevention 5. Pacemaker dependent patients. 6. Acute MI, CABG, PTCA, within the past 3 months 7. Chronic refractory angina or peripheral vascular pain; 8. Valvular heart disease requiring repair or replacement; 9. Need for chronic intermittent inotropic therapy; 10. Malignancy: evidence of disease within the previous 5 years; 11. Known HIV infection or immunodeficiency state; 12. Chronic active viral infection (such as hepatitis B or C); 13. Severe systemic infection: defined as patients undergoing treatment with antibiotics; 14. Active myocarditis or early postpartum cardiomyopathy (within the first 6-months of delivery); 15. 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; 16. Patient is pregnant, of childbearing potential and not using adequate contraceptive methods, or nursing.; 17. Patient scheduled for hospice care; 18. 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).


Study is Available At:


Original ID:

Pro00002132


NCT ID:

NCT01124136


Secondary ID:

0708-0211


Study Acronym:

Neurostim


Brief Title:

Neurostimulation of Spinal Nerves That Affect the Heart


Official Title:

Evaluation of the Effect of Neurostimulation in Patients With Symptomatic Heart Failure


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Methodist Hospital System


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jerry Estep, MD
Principal Investigator
Methodist Hospital DeBakey Heart & Vascular Center

Study Dates

Start Date:May 2010
Completion Date:November 2018
Completion Type:Anticipated
Primary Completion Date:October 2018
Primary Completion Type:Anticipated
Verification Date:January 2018
Last Changed Date:January 10, 2018
First Received Date:May 10, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Markers of efficacy
Time Frame:Average: till the end of the study
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Markers of device-device interaction
Time Frame:2 years
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Markers of cardiovascular safety
Time Frame:2 years
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Device
Name:Neurostimulation + Medication Management (Standard
Description:In addition to medication management, adding investigational implanted neurostimulator to heart
Arm Name:Neurostimulation + Medication management
Other Name:Neurostimulator and medication management
Intervention Type:Drug
Name:Standard of Care (Control)
Description:Standard of Care Therapy consists of medication management only to support heart for rhythm, anticoagulation, and rate, and comorbid symptoms, i.e. diuretics, lipid lowering.
Arm Name:Neurostimulation + Medication management
Other Name:Standard Care, Medical Management only

Study Arms

Study Arm Type:Other
Arm Name:Standard of Care (Control)
Description:Standard of Care treatment is medication management only. Heart failure medications control symptoms and comorbidities, i.e. blood thinners, lipid lowering, and diuretics, and manage heart function, i.e. heart rhythm, rate, and pumping strength.
Study Arm Type:Experimental
Arm Name:Neurostimulation + Medication management
Description:Investigational nerve stimulator device implanted to heart plus standard medication therapy.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Jerry Estep, MD
Agency Class:Other
Agency Type:Collaborator
Agency Name:The Methodist Hospital System

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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