Clinical trial NCT01124136: Neurostimulation of Spinal Nerves That Affect the Heart
Official title: Evaluation of the Effect of Neurostimulation in Patients With Symptomatic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure
Neurostimulation
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Methodist Hospital Research Institute
First posted: 2010-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Heart failure treatment standard of care (SOC) consists of medication management to support heart and manage symptoms. In this study, patients will receive the neurostimulator + SOC or SOC only.
Primary purpose: TREATMENT

Brief 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.

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 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).

Primary outcomes:
measure: Markers of cardiovascular safety
timeFrame: 2 years
measure: Markers of device-device interaction
timeFrame: 2 years
measure: Markers of efficacy
timeFrame: Average: till the end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
Study officials:
affiliation: Methodist Hospital DeBakey Heart & Vascular Center
name: Jerry Estep, MD
role: PRINCIPAL_INVESTIGATOR
References: