Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528366
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Heart Failure With Reduced Ejection Fraction Adjuvant Therapy With Neurostimulation and Chlorella Pyrenoidosa HD-tDCS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HD-tDCS
Brief 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 shamcontrol 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 5gday containing 4mcg of B12 from organic Chlorella pyrenoidosa in tablets Registration with Health Surveillance AnvisaMinistry of Health MSBrazil No 67273000 - 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None