Betaine for Heart Failure

Recruiting in Palo Alto (17 mi)

Overseen by Timothy R Morgan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Southern California Institute for Research and Education

Must be taking: Insulin sensitizers, Sulfonylureas

Must not be taking: Injectable insulin, Corticosteroids

Disqualifiers: Liver disease, Alcohol abuse, Heart failure, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Betaine (trimethyglycine) is a food supplement that is approved for sale in the United States without a prescription. In this study, betaine will be provided to patients as a powder that can be mixed with aqueous solutions and consumed orally.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use betaine or S-adenosylmethionine supplements during the study. If you are using injectable insulin or oral corticosteroids, you may not be eligible to participate.

How is the drug Betaine different from other heart failure treatments?

Betaine (trimethyglycine) is unique for heart failure treatment as it is not commonly used for this condition, unlike trimetazidine, which is known for its antioxidant properties and ability to improve cardiac metabolism. Betaine's potential benefits in heart failure may relate to its role in cellular metabolism and methylation processes, which are different from the mechanisms of standard heart failure drugs. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults aged 18-75 with non-alcoholic fatty liver disease, elevated ALT levels (a liver enzyme), and normal platelet counts. They must not have severe liver or kidney issues. Group 1 specifically includes diabetic patients with high fasting blood sugar or HgA1c levels.

Inclusion Criteria

I am between 18 and 75 years old.

I have been diagnosed with non-alcoholic fatty liver disease.

Alanine aminotransferase (ALT) levels ≥60 IU/mL

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 grams of betaine per day for the first 4 weeks, followed by randomization to either continue 4 grams or increase to 8 grams per day for an additional 8 weeks

12 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person) at 4 and 12 weeks post-treatment

Treatment Details

Interventions

• Betaine (trimethyglycine) (Dietary Supplement)

Trial Overview The study tests two different doses of Betaine, a dietary supplement taken orally as a powder mixed in liquid. It aims to see if Betaine can improve liver health in people with fatty liver disease and type 2 diabetes.

Participant Groups

Group I: diabetic patients with NAFLD Active Control 1 Intervention

Patients will be prescribed 4 grams of betaine/day (2 grams PO BID) for the first 4 weeks of the study. After 4 weeks, patients in each cohort will be randomized (1:1) to continue receiving betaine 4 grams per day or increase to 8 grams per day for an additional 8 weeks.

Group II: non-diabetics with NAFLD Active Control 1 Intervention

Patients will be prescribed 4 grams of betaine/day (2 grams PO BID) for the first 4 weeks of the study. After 4 weeks, patients in each cohort will be randomized (1:1) to continue receiving betaine 4 grams per day or increase to 8 grams per day for an additional 8 weeks.

Betaine (trimethyglycine) is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Betaine for:

• Homocystinuria

🇺🇸 Approved in United States as Cystadane for:

• Homocystinuria

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

VA Long Beach Healthcare System Long Beach, CA

Who Is Running the Clinical Trial?

Southern California Institute for Research and Education Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Trimetazidine: a meta-analysis of randomised controlled trials in heart failure. [2013] To explore whether trimetazidine could improve symptoms, cardiac functions and clinical outcomes in patients with heart failure (HF).

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Comparative trial of efficacy of trimethasidine MB and 3-(2,2,2-trimethylhydrasine) propionate dihydrate in chronic heart failure]. [2016] To study efficacy of the myocardial cytoprotector trimethasidine MB and metabolic drug 3-(2,2,2-trimethylhydrasine) propionate dihydrate (3-TMHP) in the treatment of chronic cardiac failure (CCF).

3. Poland pubmed.ncbi.nlm.nih.gov

Effects of trimetazidine in patients with severe chronic heart failure with reduced left ventricular ejection fraction: A prospective, randomized, open-label, cross-over study. [2022] Trimetazidine (TMZ) modulates cardiac metabolism, but its use in heart failure remains controversial. The aim of the study was to evaluate the effects of TMZ on exercise capacity, left ventricular ejection fraction (LVEF), mortality, and quality of life in stable patients with heart failure with reduced left ventricular ejection fraction (HFrEF).

4. Switzerland pubmed.ncbi.nlm.nih.gov

The effect of trimetazidine added to pharmacological treatment on all-cause mortality in patients with systolic heart failure. [2015] The anti-ischemic agent trimetazidine (TMZ) added to pharmacological treatment appears to have positive effects on cardiac parameters of patients with heart failure (HF) as a result of specific antioxidant properties.

5. United States pubmed.ncbi.nlm.nih.gov

Effects of trimetazidine in nonischemic heart failure: a randomized study. [2016] Heart failure (HF) is associated with changes in myocardial metabolism that lead to impairment of contractile function. Trimetazidine (TMZ) modulates cardiac energetic efficiency and improves outcomes in ischemic heart disease. We evaluated the effects of TMZ on left ventricular ejection fraction (LVEF), cardiac metabolism, exercise capacity, O2 uptake, and quality of life in patients with nonischemic HF.