Heart Failure With Reduced Ejection Fraction: Adjuvant Therapy With Neurostimulation and Chlorella Pyrenoidosa (HD-tDCS)
NCT Number: NCT06528366
Acronym: HD-tDCS
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure, Reduced Ejection Fraction|Vitamin B12 Deficiency
Interventions: DIETARY_SUPPLEMENT: Chlorella pyrenoidosa|DEVICE: High Definition Transcranial Direct Current Stimulation
Sponsor: Federal University of Paraíba
Collaborators: The City College of New York
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2023-09-26
Completion Date: 2024-08-30
Locations: Federal University of Paraíba, João Pessoa, Paraiba, 58051-900, Brazil

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.

Primary Outcome Measures: Change B12, Change B12 (above 148pmol/L), After five days and after thirty days|IL-6 Blood Analysis Biochemical, Change IL-6 (below 10p/mL), After five days and after thirty days|TNF alfa Blood Analysis Biochemical, Change TNF alfa (below 2,8p/g/mL), After five days and after thirty days
Secondary Outcome Measures: Change Methylmalonic Acid Blood Analysis Biochemical, Change Methylmalonic Acid (below 270nmol/L), After five days and after thirty days|Change Homocysteine Blood Analysis Biochemical, Change Homocysteine (below 12nmol/L), After five days and after thirty days|Change Pro_BNP Blood Analysis Biochemical, Change Pro_BNP (below 1000pg/mL), After five days and after thirty days