Neurostimulation of Spinal Nerves That Affect the Heart

NCT01124136 | Unknown DMC FDA Device

• 2 other identifiers: Pro000021320708-0211
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; Neurostimulation

Outcome Measures

Primary Outcomes (3)

• Markers of cardiovascular safety

  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.

  2 years

• Markers of device-device interaction

  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

  2 years

• Markers of efficacy

  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.

  Average: till the end of the study

Study Arms (2)

Neurostimulation + Medication management

EXPERIMENTAL

Investigational nerve stimulator device implanted to heart plus standard medication therapy.

Device: Neurostimulation + Medication Management (Standard of Care); Drug: Standard of Care (Control)

Standard of Care (Control)

OTHER

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.

Drug: Standard of Care (Control)

Interventions

Neurostimulation + Medication Management (Standard of Care) DEVICE

In addition to medication management, adding investigational implanted neurostimulator to heart

Also known as: Neurostimulator and medication management

Neurostimulation + Medication management

Standard of Care (Control) DRUG

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.

Also known as: Standard Care, Medical Management only

Neurostimulation + Medication management; Standard of Care (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years;
• Chronic heart failure NYHA class III-IV of ischemic and non-ischemic etiology;
• Screening Left ventricular Ejection Fraction (LVEF) ≤ 30% measured at baseline by echocardiography;
• Screening 6 minute walk test score of less than 450 meters measured at baseline;
• 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);
• On standard optimal medical therapy for CHF before medical therapy.\*
• No changes in active cardiac medications during the 1 week prior to treatment;
• 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.

You may not qualify if:

• Inability to comply with the conditions of the protocol;
• Inability to perform cardiopulmonary exercise test due to mechanical physical limitations
• Presence of a transplanted tissue or organ or LVAD (or the expectation of the same 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 (such as hepatitis B or C);
• Severe systemic infection: defined as patients 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;

Sponsors & Collaborators

• Jerry Estep, MD: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jerry Estep, MD

  Methodist Hospital DeBakey Heart & Vascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 14, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (1)