跳至主要内容
临床试验/NCT06528366
NCT06528366进行中(未招募)不适用

High Definition Transcranial Continuous Current Stimulation and Consumption of Chlorella Pyrenoidosa as Adjuvant Treatment for Heart Failure With Reduced Ejection Fraction

Federal University of Paraíba2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
28
试验地点
2
主要终点
IL-6 Blood Analysis Biochemical

研究概览

简要总结

Reduced ejection fraction heart failure (HFrEF) is a complex and multifactorial condition. It is characterized by a decrease in the ability of the left ventricle to eject blood effectively during systole, resulting in an ejection fraction of less than 40%. This insufficiency in blood pumping leads to inadequate tissue perfusion and a series of adverse physiological adaptations that further compromise cardiac function, representing an important challenge in conducting treatment. The pathophysiology of HFrEF involves multiple mechanisms starting from the remodeling of the left ventricle in the face of some initial aggression, such as a heart attack, which culminates in a progressive deterioration of the contractile function. Additionally, neurohormonal systems are activated in response to the decrease in cardiac output, resulting in hyperactivation of the sympathetic nervous system and the renin-angiotensin-aldosterone axis, which leads to the activation of inflammatory cascades, mainly involving Interleukin 6 (IL-6) and Tumor Necrosis Factor Alpha (TNF-alfa), and disease progression. HFrEF is more prevalent in elderly populations and leads to increased hospital admissions. Furthermore, B12 depletion is more common in the elderly population and these two associated factors, functional impairment of the heart, disruption in the inflammatory cascade and depletion of nutrients, such as vitamin B12, can impact patients; quality of life in the long term. The reduction in B12 levels leads to changes in the cardiac and brain systems, due to the increase in homocysteine and the triggering of the inflammatory cascade. B12 supplementation through Chlorella Pyrenoidosa (microalgae - functional food) reduces cardiac damage and modulate the inflammatory cascade. And also High-Density Transcranial Direct Current Stimulation (HD-tDCS), a non-invasive technique capable of modulating neuronal excitability and inducing anti-inflammatory effects. In this sense, the objective is to evaluate the effects of HD-tDCS and the consumption of Chlorella Pyrenidosa to improve B12 levels and inflammatory response in patients with HFrEF.

详细描述

This study is a controlled, double-blind, randomized, crossover model clinical trial involving 28 participants with HFrEF admitted to a hospital for surgery and post-surgical outpatient care. Assessments will be carried out at baseline and after treatments through nutritional, clinical and laboratory assessment. The protocol is divided into two phases: the hospital phase with the implementation of the HD-tDCS protocol and the outpatient phase with the implementation of the Chlorella Pyrenoidosa protocol. The randomization of participants divides them into two groups: the active group that receives the intervention and the sham/control group that does not receive the intervention. In the hospital phase of the research, the protocol with HD-tDCS must be started before the surgical procedure, consisting of 5 sessions, applied once a day, for a period of up to 5 days before surgery, with stimulation in the Dorsolateral Prefrontal Cortex, with an intensity of 4mA and duration of 20 minutes each, with anodal stimulus. After post-surgery, at hospital discharge, the washout period of the groups is considered, in this phase another assessment of the group is considered and these are inverted, where the sham group in the previous phase becomes the active group at this stage and vice versa. The active group will receive the intervention through Chlorella pyreinodosa, the protocol in this phase is guided by the consumption of Chlorella p. in a home environment for 30 days until returning for evaluation from surgery, with the active group consuming 10 tablets, 5g/day, containing 4mcg of B12 from organic Chlorella pyrenoidosa in tablets (Registration with Health Surveillance (Anvisa)/Ministry of Health (MS)/Brazil No. 6.7273.000 - classification of functional food) during a period of thirty days and de control group will not receive. After this period, the active group and the control group must return for nutritional assessment and collection of final exams.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

The research includes the responsible researcher, assistant and collaborator. The Collaborating Researcher is responsible for applying the technique to the patient not knowing which stimulus will be true or sham. He must apply the research tools and fill out de forms. The Collaborating Researcher should alert the Main Researcher and Assistant Research if regards signs or symptoms in patient resulting adverse effects.

In this way, the patient and the Collaborating Researcher are blinding.

入排标准

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

入选标准

  • Patients with stable HFrEF diagnosis and surgical indication;
  • Adults and elderly people (20 to 80 years old);
  • Able to respond to commands and give consent to participate in the research;
  • Able to respond to simple commands and provide informed consent.

排除标准

  • Patients with a clinical history of neuromuscular or cognitive instability,
  • Pregnancy and contraindications for receiving neurostimulation (such as cardiac pacemakers and metallic brain implants);
  • Patients with contraindications to the use of Chlorella (gastritis, esophagitis, peptic ulcers),;
  • Patients with stroke and tumors.

结局指标

主要结局

IL-6 Blood Analysis Biochemical

时间窗: After five days and after thirty days

Change IL-6 (below 10p/mL)

TNF alfa Blood Analysis Biochemical

时间窗: After five days and after thirty days

Change TNF alfa (below 2,8p/g/mL)

Change B12

时间窗: After five days and after thirty days

Change B12 (above 148pmol/L)

次要结局

  • Change Homocysteine Blood Analysis Biochemical(After five days and after thirty days)
  • Change Methylmalonic Acid Blood Analysis Biochemical(After five days and after thirty days)
  • Change Pro_BNP Blood Analysis Biochemical(After five days and after thirty days)

研究者

发起方
Federal University of Paraíba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suellen Andrade

PhD Suellen Marinho Andrade

Federal University of Paraíba

研究点 (2)

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