Neurostimulation of Spinal Nerves That Affect the Heart (Neurostim)
Evaluation of the Effect of Neurostimulation in Patients With Symptomatic Heart Failure
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Texas
-
Houston、Texas、アメリカ、77030
- Methodist Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion
- 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.
Exclusion
- 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;
- 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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Neurostimulation + Medication management
Investigational nerve stimulator device implanted to heart plus standard medication therapy.
|
In addition to medication management, adding investigational implanted neurostimulator to heart
他の名前:
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.
他の名前:
|
他の:Standard of Care (Control)
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.
|
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.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Markers of cardiovascular safety
時間枠:2 years
|
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
時間枠:2 years
|
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
時間枠:Average: till the end of the study
|
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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Jerry Estep, MD、Methodist Hospital DeBakey Heart & Vascular Center
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
慢性心不全の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)
Neurostimulation + Medication Management (Standard of Care)の臨床試験
-
Compedica IncProfessional Education and Research Institute募集
-
DeRoyal Industries, Inc.Lincoln Memorial University完了皮膚感作 | 機械的、熱的、および放射線刺激に対する皮膚反応アメリカ
-
University of PittsburghShadyside Hospital Foundation完了