L-Carnitine for Heart Failure

Overseen By Amy Freeman, RN

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: Stage 5 kidney disease, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether L-Carnitine, a natural substance that helps convert fat into energy, can improve symptoms and heart function in people with heart failure. Heart failure hinders the heart's ability to pump blood, leading to fatigue, shortness of breath, and swelling. Participants will take a daily dose of L-Carnitine (also known as Levocarnitine) for three months. This trial may suit those with heart failure and some kidney issues who are not on kidney dialysis. As an Early Phase 1 trial, this research aims to understand how L-Carnitine works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that taking L-Carnitine orally can improve symptoms and increase exercise capacity in people with heart failure. This may help reduce fatigue and shortness of breath. L-Carnitine is a substance naturally produced by the body, which likely explains why most people tolerate it well.

However, some studies have reported mixed results regarding its safety for heart issues, with evidence suggesting both benefits and potential risks. The current trial is in an early stage, indicating that much remains to be learned about the safety of L-Carnitine specifically for treating heart failure. Those considering joining a trial should discuss potential risks with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for heart failure, which often include medications like ACE inhibitors, beta-blockers, and diuretics, Levocarnitine offers a unique approach. Levocarnitine is a naturally occurring amino acid derivative that plays a crucial role in energy production by helping transport fatty acids into the mitochondria. Researchers are excited about this treatment because it directly targets energy metabolism in heart cells, potentially improving heart function and offering a novel therapeutic angle. Additionally, its oral administration makes it convenient and easy for patients to incorporate into their daily routine.

What evidence suggests that L-Carnitine might be an effective treatment for heart failure?

Research suggests that L-Carnitine might help treat heart failure. One study found that people taking L-Carnitine lived longer than those who did not. Another study showed that L-Carnitine improved the heart's ability to pump blood, which is crucial for individuals with heart failure. It has also been linked to fewer symptoms and complications related to heart issues. However, some research shows mixed results. While the benefits seem promising, more studies are needed. Participants in this trial will receive an oral dose of Levocarnitine (L-Carnitine) to further evaluate its effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Chris McIntyre, MBBS DM

Principal Investigator

London Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure and mild to moderate kidney disease who can speak English and consent to participate. It's not for those pregnant, planning pregnancy, breastfeeding, severely allergic to levocarnitine or certain fillers, with advanced kidney disease (stage 5), on dialysis, or with a history of seizures.

Inclusion Criteria

Able to speak and read English

Willing and able to provide consent

I am 18 years old or older.

Exclusion Criteria

Pregnant, breastfeeding or intending pregnancy

Known allergy to levocarnitine, magnesium stearate, microcrystalline cellulose or povidone

My kidney function is very low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral L-Carnitine supplementation, 2970mg daily dose for 3 months

12 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for data completeness and retention rate

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Levocarnitine

Trial Overview

The study tests if taking L-Carnitine supplements orally helps improve symptoms and heart function in people with heart failure. The goal is also to see if it enhances their quality of life by helping the body convert fat into energy more effectively.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Oral Levocarnitine (L-Carnitine), 2970mg daily dose (990mg taken 3 times a day) for 3 months.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5406747/

Efficacy and Safety of L-Carnitine Treatment for Chronic ...

L-C treatment in CHF was associated with considerable improvement in overall efficacy (OR = 3.47, P < 0.01), left ventricular ejection fraction (LVEF) (WMD: ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002870300043003

Three-year survival of patients with heart failure caused by ...

Survival analysis with the Kaplan-Meier method showed that patients' survival was statistically significant (P < .04) in favor of the L-carnitine group. L- ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07201714

NCT07201714 | Oral Carnitine in Heart Failure Patients

This study will determine whether oral L-Carnitine supplementation can improve symptoms, enhance heart function and possibly improve the quality ...

4.

mayoclinicproceedings.org

mayoclinicproceedings.org/article/s0025-6196(13)00127-4/fulltext

L-Carnitine in the Secondary Prevention of Cardiovascular ...

L-carnitine is associated with a 27% reduction in all-cause mortality, a 65% reduction in VAs, and a 40% reduction in anginal symptoms in patients experiencing ...

5.

bmcmedicine.biomedcentral.com

bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02477-z

l-carnitine, a friend or foe for cardiovascular disease? A ...

The effectiveness and safety of l-carnitine in CVD is unclear, with contradictory evidence showing potential cardiovascular benefits as well as ...

6.

webmd.com

webmd.com/vitamins/ai/ingredientmono-1026/l-carnitine

L-Carnitine - Uses, Side Effects, and More

Taking L-carnitine by mouth or by IV seems to improve symptoms and increase exercise ability in people with heart failure. IV products can only be given by a ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9434903/

l-carnitine, a friend or foe for cardiovascular disease? ...

The effectiveness and safety of l-carnitine in CVD is unclear, with contradictory evidence showing potential cardiovascular benefits as well as ...