NCT06528366

Heart Failure With Reduced Ejection Fraction: Adjuvant Therapy With Neurostimulation and Chlorella Pyrenoidosa (HD-tDCS)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure, Reduced Ejection Fraction
• Vitamin B12 Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Chlorella pyrenoidosa	Functional food, organically pressed into tablets (Registration with Anvisa/MS/Brazil: 6.7273.000)
DEVICE	High Definition Transcranial Direct Current Stimulation	Neuromodulation Technics, non invasive, target and safety

Timeline

• Start date: 2023-09-26
• Primary completion: 2024-08-01
• Completion: 2024-08-30
• First posted: 2024-07-30
• Last updated: 2024-07-30

Locations

1 site across 1 country: Brazil