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临床试验/NCT04099992
NCT04099992招募中不适用

Sympatho-inhibition With Mindfulness in Chronic Kidney Disease (MIND-CKD)

Emory University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Change in Mean Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency (BF)

研究概览

简要总结

This study will test whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-inhibitory effects of mindfulness meditation (MM) and restores autonomic balance in CKD patients.

详细描述

Approximately 30 million people in the US have chronic kidney disease (CKD) and are at 5-15 fold greater risk of cardiovascular (CV) disease and mortality. A major factor contributing to increased CV risk in these patients is chronic elevation of sympathetic nervous system (SNS) activity.

Patients with even minimal decrements in kidney function have significant and substantial increases in SNS activity and reactivity that are independently linked to adverse CV events. The mechanisms underlying SNS overactivity in CKD are multifactorial, and include chronic inflammation and blunted arterial baroreflex sensitivity (BRS). SNS overactivity, in turn, leads to downstream deleterious effects on ambulatory BP profiles characterized by higher daytime BP, and lack of normal reductions in nocturnal BP (i.e. nocturnal nondipping), both of which are independently linked to increased CV risk. Current treatments to combat SNS overactivity are limited to sympatholytic medications such as β-blockers, α-blockers, and clonidine; however, these pharmacologic agents are associated with long-term adverse metabolic consequences such as insulin resistance and hyperlipidemia, and often intolerable side effects such as fatigue, orthostatic hypotension, and rebound hypertension. New therapeutic strategies to safely and effectively ameliorate SNS over-activity are of paramount importance to improve clinical outcomes in this highly prevalent and high-risk patient population.

Mindfulness meditation (MM) may be one such novel, safe, and effective approach at improving hemodynamics and autonomic function in CKD. Prior studies have shown that 8 weeks of mindfulness-based stress reduction (MBSR) lowers BP in a variety of patient groups. Although the mechanisms are poorly understood, studies using indirect measures of SNS activity such as heart rate variability suggest that MM may exert its hemodynamic effects via autonomic modulation.

This study tests whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-inhibitory effects of mindfulness meditation (MM) and restores autonomic balance in CKD patients. These study aims are tested with two separate protocols.

Protocol 1 tests the sustained effects of MBSR on SNS function and BP profiles in CKD. Participants will be randomized to 8 weeks of MBSR or a health enhancement program (HEP).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

A third-party investigator outside of the research team will label both real and sham devices with a coded number so that both participants and investigators can remain double-masked during the clinical trial.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • stages III and IV CKD as defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
  • stable renal function (no greater than a decline of eGFR of 1 cc/min/1.73 m2 per month over the prior 3 months)

排除标准

  • severe CKD (eGFR<15 cc/min)
  • diabetic neuropathy
  • autonomic dysfunction
  • any serious disease that might influence survival
  • anemia with hemoglobin <10 g/dL
  • treatment with central α-agonists or monoamine oxidase (MAO) inhibitors
  • myocardial infarction or cerebrovascular accident within the past 6 months
  • uncontrolled hypertension (BP≥170/100 mm Hg)
  • low BP (BP<100/50 mm Hg)
  • bradycardia (HR<55 beats/min)
  • ongoing drug or alcohol abuse (defined as >2 drinks/day in men, and >1 drink/day in women)
  • surgery within the past 3 months
  • adjustment of antihypertensive medications within the past month
  • pregnancy or plans to become pregnant
  • psychosis
  • suicidal ideation
  • implanted electronic or metallic device such as a pacemaker
  • implanted hearing aid, bone plate, carotid stent, bone screw at or near the neck
  • carotid atherosclerosis
  • concurrent use of another stimulating device such as a transcutaneous electrical nerve stimulation (TENS) unit

结局指标

主要结局

Change in Mean Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency (BF)

时间窗: Baseline, 8 weeks

Multiunit postganglionic sympathetic nerve activity is recorded from a tungsten microelectrode inserted into the peroneal nerve with a reference microelectrode inserted in close proximity. Efferent nerve signals are amplified, filtered, rectified and integrated (time constant 0.1 s) to obtain a mean voltage display of MSNA. MSNA bursts are automatically detected using the following criteria: burst-to-noise ratio of 3:1 within a 0.5-s search window, with an average latency of 1.2-1.3 s in burst occurrence from the previous R-wave. MSNA is expressed as burst frequency measured a bursts per minute.

次要结局

  • Change in Heart Rate Assessed by 24-hour EKG Monitoring(Baseline, 8 weeks)
  • Change in Daytime Blood Pressure (BP)(Baseline, 8 weeks)
  • Change in Nocturnal Dipping of Blood Pressure (BP)(Baseline, 8 weeks)
  • Change in Baroreflex Sensitivity (BRS) Among Protocol 2 Participants(Baseline, 8 weeks)
  • Change in Tumor Necrosis Factor (TNF) Level Among Protocol 2 Participants(Baseline, 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeanie Park

Associate Professor

Emory University

研究点 (2)

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