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

NCT06528366 | Active Not Recruiting

• 1 other identifier: HD-tDCS/Chlorella p./HFREF
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Reduced Ejection Fraction; Vitamin B12 Deficiency

Keywords

High-density Transcranial Direct Current Stimulation; Vitamin B12 Deficiency; Heart Failure with Reduced Ejection Fraction; Functional Food; Chlorella pyrenoidosa

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change Methylmalonic Acid Blood Analysis Biochemical

  After five days and after thirty days

• Change Homocysteine Blood Analysis Biochemical

  After five days and after thirty days

• Change Pro_BNP Blood Analysis Biochemical

  After five days and after thirty days

Study Arms (4)

Experimental Group HD-tDCS (Hospital fase)

EXPERIMENTAL

Experimental group HD-tDCS will be started at hospital fase when the patients will be randomly enrolled into tis group. They will receive 3mA current for 20 minutes with anodal stimulation through HD-tDCS (4x1) to the left dorsolateral prefrontal cortex, with 5 sessions on 5 consecutive days and before the surgical procedure.

Device: High Definition Transcranial Direct Current Stimulation

Sham Group (Hospital Fase)

SHAM COMPARATOR

Sham Group (Hospital Fase) will be started at hospital fase when the patients will be randomly enrolled into tis group. They will receive simulated HD-tDCS anodic current (4x1) to the left dorsolateral prefrontal cortex with 3mA that accelerates for 30 seconds and decelerates for another 30 seconds, 5 sessions on 5 consecutive days and before the surgical procedure.

Device: High Definition Transcranial Direct Current Stimulation

Experimental Group Chlorella pyrenoidosa (Outpatient phase)

ACTIVE COMPARATOR

The groups are inverted due to the crossover design, so the previous sham group becomes the active group for Chlorella p consumption after the washout . So, this group must consume 10 tablets per day of Chlorella p for 30 days. (5g/day) and must return within 30 days for evaluation.

Dietary Supplement: Chlorella pyrenoidosa

Control Group (Outpatient phase)

NO INTERVENTION

This group was inverted using the crossover method, so the active group for HD-tDCS in the previous phase and after the washout is inverted and becomes the control group in this phase. So, they will not receive intervention and must return within 30 days for evaluation.

Interventions

Chlorella pyrenoidosa DIETARY_SUPPLEMENT

Functional food, organically pressed into tablets (Registration with Anvisa/MS/Brazil: 6.7273.000)

Experimental Group Chlorella pyrenoidosa (Outpatient phase)

High Definition Transcranial Direct Current Stimulation DEVICE

Neuromodulation Technics, non invasive, target and safety

Also known as: HD-tDCS

Experimental Group HD-tDCS (Hospital fase); Sham Group (Hospital Fase)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead
• The City College of New York: collaborator

Study Sites (1)

Federal University of Paraíba

João Pessoa, Paraíba, 58051-900, Brazil

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Vanessa M Cintra, Msc

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Suellen Marinho Andrade

Model Details: Crossover Study Experimental Group Hospital phase (Group 1): Patients will receive 3mA current for 20 minutes with anodal stimulation through HD-tDCS (4x1) with 5 sessions on 5 consecutive days and before the surgical procedure. Control Group (2) Sham: Patients receive the simulated HD-tDCS anodic current (4x1) with 3mA that accelerates for 30 seconds and decelerates for another 30 seconds, 5 sessions on 5 consecutive days and before the surgical procedure . Washout period - surgery and recovery for discharge (on average 15 days). Experimental Group Outpatient phase (Group 1) - active for Chlorella pyrenoidosa - consume 10 tablets per day of Chlorella p for 30 days. (5g/day) and must return within 30 days for evaluation. Control Group 2 - will not consumption of Chlorella pyrenoidosa and must return within 30 days for evaluation.

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 30, 2024
• Study Start: September 26, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 30, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)