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

July 26, 2024 updated by: Suellen Andrade, Federal University of Paraíba

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraiba
      • João Pessoa, Paraiba, Brazil, 58051-900
        • Federal University of Paraíba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group HD-tDCS (Hospital fase)
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
Neuromodulation Technics, non invasive, target and safety
Other Names:
  • HD-tDCS
Sham Comparator: Sham Group (Hospital Fase)
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
Neuromodulation Technics, non invasive, target and safety
Other Names:
  • HD-tDCS
Active Comparator: Experimental Group Chlorella pyrenoidosa (Outpatient phase)
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
Functional food, organically pressed into tablets (Registration with Anvisa/MS/Brazil: 6.7273.000)
No Intervention: Control Group (Outpatient phase)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change B12
Time Frame: After five days and after thirty days
Change B12 (above 148pmol/L)
After five days and after thirty days
IL-6 Blood Analysis Biochemical
Time Frame: After five days and after thirty days
Change IL-6 (below 10p/mL)
After five days and after thirty days
TNF alfa Blood Analysis Biochemical
Time Frame: After five days and after thirty days
Change TNF alfa (below 2,8p/g/mL)
After five days and after thirty days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change Methylmalonic Acid Blood Analysis Biochemical
Time Frame: After five days and after thirty days
Change Methylmalonic Acid (below 270nmol/L)
After five days and after thirty days
Change Homocysteine Blood Analysis Biochemical
Time Frame: After five days and after thirty days
Change Homocysteine (below 12nmol/L)
After five days and after thirty days
Change Pro_BNP Blood Analysis Biochemical
Time Frame: After five days and after thirty days
Change Pro_BNP (below 1000pg/mL)
After five days and after thirty days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Paraíba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The City College of New York

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vanessa M Cintra, Msc, Federal University of Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HD-tDCS/Chlorella p./HFREF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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