心不全研究のための神経心臓療法 (NECTAR-HF) (NECTAR-HF)
心不全研究のための神経心臓療法
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The objectives of this study are to assess the impact of right vagal nerve stimulation on left ventricular remodeling, functional capacity, quality of life, and other measures in heart failure patients over a 6-month period. In addition, the study will assess the safety of the NECTAR-HF study system over an 18-month period.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
London、イギリス、SE5 9RS
- King's College Hospital NHS Foundation Trust
-
-
England
-
Bristol、England、イギリス、BS2 8HW
- University Hospitals Bristol, NHS Foundation Trust
-
Liverpool、England、イギリス、L14 3PD
- Liverpool Heart and Chest Hospital, NHS Foundation Trust
-
London、England、イギリス、W1G 8PH
- The Heart Hospital, University College London Hospitals, NHS Foundation Trust
-
London、England、イギリス、W2 1NY
- Imperial College Healthcare NHS Trust, St. Mary's Hospital
-
-
-
-
-
Milan、イタリア、20162
- Azienda Ospedaliera Niguarda Cà Granda
-
Naples、イタリア、80131
- A. O. Dei Colli - Monaldi
-
Pavia、イタリア、27100
- Policlinico San Matteo
-
-
-
-
-
Eindhoven、オランダ、5623EJ
- Catharina Ziekenhuis Eindhoven
-
Utrecht、オランダ、3584CX
- UMC Utrecht
-
-
-
-
-
Barcelona、スペイン、08036
- Hospital Clinic de Barcelona
-
Madrid、スペイン、28041
- Hospital Doce de Octubre
-
-
Navarre
-
Pamplona、Navarre、スペイン、31008
- Clínica Universitaria de Navarra, Avenida Pio XII s/n
-
-
-
-
-
Prague、チェコ、15030
- Nemocnice Na Homolce
-
-
-
-
-
Göttingen、ドイツ、37075
- Universitätsmedizin Göttingen
-
Hamburg、ドイツ、20246
- Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf
-
Leipzig、ドイツ、04103
- Universitätsklinikum Leipzig
-
-
Brandenburg
-
Bernau bei Berlin、Brandenburg、ドイツ、16321
- Immanuel Klinikum Bernau Herzzentrum Brandenburg
-
-
-
-
-
Lille、フランス、59037
- CHRU de Lille - Hôpital Cardiologique
-
-
Nancy
-
Vandœuvre-lès-Nancy、Nancy、フランス、54500
- Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy
-
-
-
-
-
Brussels、ベルギー、1200
- UCL Bruxelles
-
-
参加基準
適格基準
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 Criteria:
- Age 18 or above, and of legal age to give informed consent specific to national laws
- Willing and capable of providing informed consent
- Capable of participating in all testing associated with this clinical investigation
- Stable symptomatic heart failure NYHA class II-III
- Left ventricular (LV) ejection fraction equal or smaller than 35 %
- Left ventricular end diastolic diameter (LVEDD) of 5.5 cm or greater
- Prescribed to optimal pharmacologic therapy
Exclusion Criteria:
- QRS larger than 130 ms
- Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment
- Patients unable to tolerate anesthesia required for implant
- Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 90 days before enrollment
- Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
- Patients with persistent or permanent atrial fibrillation within 90 days prior to enrollment
- Pacemaker indicated patients
- Patients whose heart failure is due to congenital heart disease
- Patients who have started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi-PAP,APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment
- Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- Patients with documented chronic obstructive lung disease
- Patients on or indicated for renal dialysis
- Type 1 diabetic patients
- Type 2 diabetic patients that have been treated with insulin for more than 5 years prior to enrollment
- Patients with a life expectancy of less than 12 months per physician judgment
- Patients involved in any concurrent clinical investigation
- Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
- Patients with a prior cardiac transplant or expecting a heart transplant operation within the next 12 months
- Patients with a prior vagotomy
- Patients with prior or existing vagal nerve stimulation treatment
- Patients implanted with any active implantable medical device other than a left sided single or dual chamber implantable cardioverter defibrillator (ICD) with bipolar sensing, or a left sided CRT device with each sensing channel programmed to either bipolar sensing or no sensing. All CRT patients must have had CRT for at least 1 year prior to enrollment. The total number of CRT patients will not exceed 30
- Patients with locally implanted semi-/permanent devices such as vascular catheters, etc. that would interfere with the NECTAR-HF study system
- Patients with previously implanted devices on the right side that became infected before removal
- Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system on the right side of the neck (Thyroid/parathyroid, carotid artery etc)
- Patients with known recurrent nerve paralysis
- Patients who have undergone radiotherapy for thyroid disease/cancer
- Patients who have existing or prior tracheotomy
- Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace
- Patients with carotid murmur/vascular bruit/carotid artery lesion
- Patients with known/suspected vascular malformation in carotid/vertebral circulatory bed
- Patients who are likely to need an MRI of the neck area because of previous medical conditions
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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Therapy
Implant of investigational device system for vagus nerve stimulation. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The experimental arm was receiving vagus nerve stimulation during the first 6 months after implant. Titration during the randomization phase with delivery of highest tolerable by patient stimulation current. Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current. |
Vagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region. Amplitude of the chronically delivered vagus nerve stimulation in the experimental arm was adjusted to the highest tolerable by patient value. No chronically delivered vagus nerve stimulation in the control arm during the randomization phase. Amplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study. Blood draw before implant and 6 months after implant at the end of the randomization phase. |
|
偽コンパレータ：Control
Implant of investigational device system for vagus nerve stimulation. Control group was implanted with study system like the experimental arm, but was not receiving experimental vagus nerve stimulation therapy during the first 6 months after implant. 6-month after implant a cross-over took place and the control arm also started to receive experimental vagus nerve stimulation. Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current. |
Vagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region. Amplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study. Blood draw before implant and 6 months after implant at the end of the randomization phase. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Left Ventricular End-systolic Dimension (LVESD)
時間枠：LVESD at Baseline and at 6-months post Baseline
|
Change in the Left ventricular end-systolic dimension (LVESD) between Baseline and the value at the end of the randomization phase (6 months after Baseline) i.e. 6 months after vagus nerve stimulation in the THERAPY Arm. No Vagus nerve stimulation during that time window in the CONTROL Arm. The sign (- ) indicates a reduction in the LVESD. Minus means a reduction in LVESD. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline). |
LVESD at Baseline and at 6-months post Baseline
|
|
Percentage of Surviving Participants
時間枠：18-months
|
As pre-specified in the study protocol, the All-cause Survival endpoint combined both groups into one analysis population. Subjects contributed data according to the follow-up period during they received VNS therapy (Implant through 18 months for Therapy subjects, 6 through 18 months for Control subjects). Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded. |
18-months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
LVEF, Left Ventricular Ejection Fraction
時間枠：LVEF at Baseline and at 6-months after Baseline
|
LVEF, left ventricular ejection fraction. |
LVEF at Baseline and at 6-months after Baseline
|
|
Exercise Capacity, Peak VO2
時間枠：Measurements at Baseline and at 6-months after Baseline
|
Assessment of functional capacity (e.g., peak VO2) as measures related to patient heart failure status. |
Measurements at Baseline and at 6-months after Baseline
|
|
LVESV, Left Ventricular End Systolic Volume
時間枠：At Baseline and at 6-months after Baseline
|
Measurements of LVESV, left ventricular end systolic volume at Baseline and 6 months after Baseline in the Control Arm and in the Therapy Arm |
At Baseline and at 6-months after Baseline
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Faiez Zannad, M.D.、Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy
出版物と役立つリンク
一般刊行物
- De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F. Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF. Eur J Heart Fail. 2014 Jun;16(6):692-9. doi: 10.1002/ejhf.80. Epub 2014 May 20.
- Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.
- De Ferrari GM, Stolen C, Tuinenburg AE, Wright DJ, Brugada J, Butter C, Klein H, Neuzil P, Botman C, Castel MA, D'Onofrio A, de Borst GJ, Solomon S, Stein KM, Schubert B, Stalsberg K, Wold N, Ruble S, Zannad F. Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial. Int J Cardiol. 2017 Oct 1;244:229-234. doi: 10.1016/j.ijcard.2017.06.036. Epub 2017 Jun 10.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (推定)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- NECTAR-1109
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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。