Heart Failure, Reduced Ejection FractionHD-tDCSNCT06528366
Heart Failure With Reduced Ejection Fraction: Adjuvant Therapy With Neurostimulation and Chlorella Pyrenoidosa (HD-tDCS)
A study testing Chlorella pyrenoidosa and High Definition Transcranial Direct Current Stimulation in people with Heart Failure, Reduced Ejection Fraction and Vitamin B12 Deficiency, run by Federal University of Paraíba at 1 site in Brazil.
Trial 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%. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure, Reduced Ejection Fraction, Vitamin B12 Deficiency
- What is being tested?
- Chlorella pyrenoidosa and High Definition Transcranial Direct Current Stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Sep 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Chlorella pyrenoidosa, High Definition Transcranial Direct Current Stimulation
- Keywords
- High-density Transcranial Direct Current Stimulation, Vitamin B12 Deficiency, Heart Failure with Reduced Ejection Fraction, Functional Food, Chlorella pyrenoidosa
- Medical subject headings
- Heart Failure, Systolic, Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorella pyrenoidosaDietary supplement
Functional food, organically pressed into tablets (Registration with Anvisa/MS/Brazil: 6.7273.000)
High Definition Transcranial Direct Current StimulationDevice
Also called HD-tDCS
Neuromodulation Technics, non invasive, target and safety
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change B12
Change B12 (above 148pmol/L)
Measured: After five days and after thirty days
IL-6 Blood Analysis Biochemical
Change IL-6 (below 10p/mL)
Measured: After five days and after thirty days
TNF alfa Blood Analysis Biochemical
Change TNF alfa (below 2,8p/g/mL)
Measured: After five days and after thirty days
Secondary outcomes (3)
Change Methylmalonic Acid Blood Analysis Biochemical
Change Methylmalonic Acid (below 270nmol/L)
Measured: After five days and after thirty days
Change Homocysteine Blood Analysis Biochemical
Change Homocysteine (below 12nmol/L)
Measured: After five days and after thirty days
Change Pro_BNP Blood Analysis Biochemical
Change Pro_BNP (below 1000pg/mL)
Measured: After five days and after thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start26 Sep 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- The City College of New York
- Responsible party
- Principal investigator, Suellen Andrade, Federal University of Paraíba
- Investigators
- Vanessa M Cintra, Msc, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528366
- Sponsor's protocol ID
- HD-tDCS/Chlorella p./HFREF
- Acronym
- HD-tDCS
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Transcranial Continuous Current Stimulation and Consumption of Chlorella Pyrenoidosa as Adjuvant Treatment for Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT06528366
- Acronym / sponsor ID
- HD-tDCS / HD-tDCS/Chlorella p./HFREF
- Keywords
- High-density Transcranial Direct Current Stimulation, Vitamin B12 Deficiency, Heart Failure with Reduced Ejection Fraction, Functional Food, Chlorella pyrenoidosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Collaborators
- The City College of New York
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group HD-tDCS (Hospital fase) | Experimental | Device: High Definition Transcranial Direct Current StimulationExperimental 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. |
| Sham Group (Hospital Fase) | Sham comparator | Device: High Definition Transcranial Direct Current StimulationSham 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. |
| Experimental Group Chlorella pyrenoidosa (Outpatient phase) | Active comparator | Dietary Supplement: Chlorella pyrenoidosaThe 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. |
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorella pyrenoidosaFunctional food, organically pressed into tablets (Registration with Anvisa/MS/Brazil: 6.7273.000) | Dietary supplement | Experimental Group Chlorella pyrenoidosa (Outpatient phase) |
| High Definition Transcranial Direct Current StimulationAlso: HD-tDCSNeuromodulation Technics, non invasive, target and safety | Device | Experimental Group HD-tDCS (Hospital fase), Sham Group (Hospital Fase) |
Primary outcome
Change B12
Time frame: After five days and after thirty days
Change B12 (above 148pmol/L)
IL-6 Blood Analysis Biochemical
Time frame: After five days and after thirty days
Change IL-6 (below 10p/mL)
TNF alfa Blood Analysis Biochemical
Time frame: After five days and after thirty days
Change TNF alfa (below 2,8p/g/mL)
3 secondary outcomes
Change Methylmalonic Acid Blood Analysis Biochemical
Time frame: After five days and after thirty days
Change Homocysteine Blood Analysis Biochemical
Time frame: After five days and after thirty days
Change Pro_BNP Blood Analysis Biochemical
Time frame: After five days and after thirty days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa M Cintra, Msc principal investigator
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorella pyrenoidosa and High Definition Transcranial Direct Current Stimulation in people with Heart Failure, Reduced Ejection Fraction and Vitamin B12 Deficiency, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change B12 (time frame: After five days and after thirty days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.