Low Level Tragus Stimulation in Acute Decompensated Heart Failure
キーワード
概要
日付
最終確認済み: | 03/31/2020 |
最初に提出された: | 08/31/2016 |
提出された推定登録数: | 09/06/2016 |
最初の投稿: | 09/12/2016 |
最終更新が送信されました: | 04/08/2020 |
最終更新日: | 04/09/2020 |
実際の研究開始日: | 08/31/2016 |
一次完了予定日: | 08/31/2021 |
研究完了予定日: | 08/31/2021 |
状態または病気
介入/治療
Device: Tragus Stimulation
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: Tragus Stimulation In this group patients will receive tragus stimulation for 8 hours per day during hospital stay. | Device: Tragus Stimulation Active LLTS will be performed by use of a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear.TENS will be applied continuously for 8 hours daily (4 hours twice daily) |
No Intervention: Control group No tragus stimulation will be done |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: Patients admitted with ADHF will undergo echocardiography which is considered standard of care. If estimated LVEF is 40% patients will be enrolled in the study. Exclusion Criteria: 1. Refusal to consent 2. Complex congenital heart disease (Tetralogy of Fallot patients, single ventricle physiology) 3. Recurrent vaso-vagal syncopal episodes 4. Unilateral or bilateral vagotomy 5. Sick sinus syndrome 6. 2nd or 3rd degree AV block 7. bifascicular block or prolonged 1st degree AV block (PR>300ms) 8. Pregnant patients 9. Prisoners 10. Advanced renal dysfunction(defined as eGFR < 30, stage 4 or 5 chronic kidney disease) 11. Hepatitis C or HIV |
結果
主な結果の測定
1. Change in CRP levels [During the hospitalization(baseline,day 1, day 2, day 3 and day 4)]
2. Change in TNF-alpha levels [During the hospitalization(baseline,day 1, day 2, day 3 and day 4)]
3. Change in Interleukin (IL) levels [During the hospitalization(baseline,day 1, day 2, day 3 and day 4)]