Heart FailureEarly Phase 1NCT07201714
Oral Carnitine in Heart Failure Patients
A Early Phase 1 study testing Levocarnitine in people with Heart Failure and Carnitine Deficiency, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Heart failure is a condition in which the heart is unable to pump blood effectively, leading to symptoms like being more tired, shortness of breath, and swelling in the body. Carnitine is a naturally occurring substance in the body that plays a role in turning fat into energy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Carnitine Deficiency
- What is being tested?
- Levocarnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 12 Nov 2025to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical-pathological diagnosis of heart failure with some degree of cardiorenal syndrome
- Stage 1, 2, 3a, 3b, or 4 chronic kidney disease
- Age ≥ 18 years
- Able to speak and read English
- Willing and able to provide consent
Who cannot join
- Estimated GFR <15 mL/min/1.73m2 or Stage 5 chronic kidney disease
- Currently undergoing renal replacement therapy of any kind
- Pregnant, breastfeeding or intending pregnancy
- History of seizures of any type
- Known allergy to levocarnitine, magnesium stearate, microcrystalline cellulose or povidone
- Unable to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
About this study
Official title: Oral L-Carnitine Supplementation in Cardiorenal Heart Failure Patients
Heart failure is a condition in which the heart is unable to pump blood effectively, leading to symptoms like being more tired, shortness of breath, and swelling in the body. Carnitine is a naturally occurring substance in the body that plays a role in turning fat into energy. This study will determine whether oral L-Carnitine supplementation can improve symptoms, enhance heart function and possibly improve the quality of life in individuals with heart failure.
Read the detailed description
Heart failure (HF) is a multi-organ syndrome that is fundamentally driven by metabolic failure. Metabolic alterations include reduced fatty acid oxidation, which is the main fuel source for cardiac myocyctes in normal circumstances. Carnitine is a vitamin-like modified amino acid that is essential in the oxidation of fatty acids and has been found to be reduced in the heart failure population. Abnormalities in carnitine metabolism are thought to contribute to myocardial dysfunction, oxidative stress and inflammation. Carnitine supplementation may increase fatty acid oxidation, and therefore energy metabolism in heart failure patients, thus improving functional capacity, clinical measures and quality of life in this vulnerable patient population.
- Conditions
- Heart Failure, Carnitine Deficiency
- Being tested
- Levocarnitine
- Medical subject headings
- Heart Failure, Systemic carnitine deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocarnitineDrug
Oral L-carnitine, 2970mg daily (950mg, to be taken 3 times a day) for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Oral Levocarnitine (L-Carnitine), 2970mg daily dose (990mg taken 3 times a day) for 3 months. Receives: Drug: Levocarnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
% of eligible patients enrolled over the study period
Measured: From study start to end of study at 52 weeks
Retention Rate
% of enrolled participants completing final follow up
Measured: From enrollment to end of treatment at 6 months
Intervention adherence
Medication compliance measured by the % of prescribed L-carnitine doses taken. Pill counts will be completed at the end of the medication intervention time period at Visit 2.
Measured: From enrollment to end of study treatment at 6 months
Safety and Tolerability (adverse events)
Participants will be monitored throughout the study for any adverse events.
Measured: From enrollment to end of treatment at 6 months
Data Completeness
% of participants with complete data for each outcome
Measured: From start of study to end of study at 52 weeks
Secondary outcomes (8)
Change in Patient Reported Outcome Measurements (PROM) using the Dynamic Patient Reported Outcome Measure (d/PROM)
dPROm questionnaire is a digital application patient reported tool which uses a visual analogue scale to measure 3 domains (symptoms, health-related QoL and limitations) using a total of 12 questions. Participants will be assigned a unique unidentifiable username and password and be asked to complete the questionnaire daily over the course of the study.
Measured: From enrollment to the end of treatment at 6 months.
Change in cognitive function (Montreal Cognitive Assessment (MoCA))
The MoCA test is a validated and highly sensitive tool for the detection of mild cognitive impairment. The MoCA accurately measures short term memory; visuospatial abilities; executive functions; attention, concentration and working memory; language; and orientation to time and place.
Measured: From enrollment to the end of treatment at 6 months.
Change in cognitive function (Creyos)
Creyos is an easily administered validated and engaging cognitive assessment. Creyos uses an online platform to deliver scientifically rigorous neurocognitive tasks and batteries based on classical paradigms from cognitive psychology literature. The tests that are used in Creyos are designed to measure cognition in scientific studies and clinical trials. The brain games presented in Creyos encompass testing to assess short-term memory, reasoning, attention and verbal ability.
Measured: From enrollment to the end of treatment at 6 months.
Change in Patient Reported Outcome Measurements (PROM) using Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
KCCQ-12 is a validated and standardized commonly used PROM in the heart failure population. It consists of 12 questions that map 7 different domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy. Scores are represented on a 0-100-point scale, with lower scores representing more severe symptoms and limitations.
Measured: From enrollment to the end of treatment at 6 months.
Change in Cardiac Function (Echocardiogram)
An echocardiogram will be completed at each visit. Images will be captured in the left lateral position and standard apical 2, 3 and 4 chamber views will be recorded for analysis. Three cardiac cycles will be recorded for each time point and values will be derived for segmental and global longitudinal strain.
Measured: From enrollment to the end of treatment at 6 months.
Change in Functional Capacity (hand-grip strength (HGS)
A Smedley hand grip dynamometer will be used to measure HGS. Participants will be tested in a sitting position with shoulder adducted and neutrally rotated with the elbow flexed at 90o. The participant will be asked to squeeze the handle of the dynamometer as hard as possible for 5 seconds and then relax. The best value out of three attempts will be recorded in kilograms.
Measured: From enrollment to the end of treatment at 6 months.
Change in Functional Capacity (6-minute walk test)
The 6-minute walk test measures functional exercise capacity in an objective way. The test procedure is used when a patient would not be able to perform a cardiopulmonary exercise test. (stress test) due to chronic disease (eg Heart Failure)
Measured: From enrollment to the end of treatment at 6 months.
Change in Functional Capacity using Sit to Stand Test (STST)
The sit to stand test has been shown to be a reliable alternative to the 6-minute walk test and may be used in patients who are assessed or who feel that they may not be able to complete a 6-minute walk test due to mobility issues.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start12 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional, pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Chris McIntyre, MBBS DM, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201714
- Sponsor's protocol ID
- 16078
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet determined
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral L-Carnitine Supplementation in Cardiorenal Heart Failure Patients
- ClinicalTrials.gov ID
- NCT07201714
- Acronym / sponsor ID
- 16078
- Conditions
- Heart Failure, Carnitine Deficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 2025 (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.
Heart failure is a condition in which the heart is unable to pump blood effectively, leading to symptoms like being more tired, shortness of breath, and swelling in the body. Carnitine is a naturally occurring substance in the body that plays a role in turning fat into energy. This study will determine whether oral L-Carnitine supplementation can improve symptoms, enhance heart function and possibly improve the quality of life in individuals with heart failure.
Detailed description
Heart failure (HF) is a multi-organ syndrome that is fundamentally driven by metabolic failure. Metabolic alterations include reduced fatty acid oxidation, which is the main fuel source for cardiac myocyctes in normal circumstances. Carnitine is a vitamin-like modified amino acid that is essential in the oxidation of fatty acids and has been found to be reduced in the heart failure population. Abnormalities in carnitine metabolism are thought to contribute to myocardial dysfunction, oxidative stress and inflammation. Carnitine supplementation may increase fatty acid oxidation, and therefore energy metabolism in heart failure patients, thus improving functional capacity, clinical measures and quality of life in this vulnerable patient population.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional, pilot study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: LevocarnitineOral Levocarnitine (L-Carnitine), 2970mg daily dose (990mg taken 3 times a day) for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical-pathological diagnosis of heart failure with some degree of cardiorenal syndrome
- Stage 1, 2, 3a, 3b, or 4 chronic kidney disease
- Age ≥ 18 years
- Able to speak and read English
- Willing and able to provide consent
Key exclusion criteria (6 listed)
- Estimated GFR <15 mL/min/1.73m2 or Stage 5 chronic kidney disease
- Currently undergoing renal replacement therapy of any kind
- Pregnant, breastfeeding or intending pregnancy
- History of seizures of any type
- Known allergy to levocarnitine, magnesium stearate, microcrystalline cellulose or povidone
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 |
|---|---|---|
| LevocarnitineOral L-carnitine, 2970mg daily (950mg, to be taken 3 times a day) for 3 months. | Drug | Intervention |
Primary outcome
Recruitment Rate
Time frame: From study start to end of study at 52 weeks
% of eligible patients enrolled over the study period
Retention Rate
Time frame: From enrollment to end of treatment at 6 months
% of enrolled participants completing final follow up
Intervention adherence
Time frame: From enrollment to end of study treatment at 6 months
Medication compliance measured by the % of prescribed L-carnitine doses taken. Pill counts will be completed at the end of the medication intervention time period at Visit 2.
Safety and Tolerability (adverse events)
Time frame: From enrollment to end of treatment at 6 months
Participants will be monitored throughout the study for any adverse events.
Data Completeness
Time frame: From start of study to end of study at 52 weeks
% of participants with complete data for each outcome
8 secondary outcomes
Change in Patient Reported Outcome Measurements (PROM) using the Dynamic Patient Reported Outcome Measure (d/PROM)
Time frame: From enrollment to the end of treatment at 6 months.
Change in cognitive function (Montreal Cognitive Assessment (MoCA))
Time frame: From enrollment to the end of treatment at 6 months.
Change in cognitive function (Creyos)
Time frame: From enrollment to the end of treatment at 6 months.
Change in Patient Reported Outcome Measurements (PROM) using Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: From enrollment to the end of treatment at 6 months.
Change in Cardiac Function (Echocardiogram)
Time frame: From enrollment to the end of treatment at 6 months.
Change in Functional Capacity (hand-grip strength (HGS)
Time frame: From enrollment to the end of treatment at 6 months.
Change in Functional Capacity (6-minute walk test)
Time frame: From enrollment to the end of treatment at 6 months.
Change in Functional Capacity using Sit to Stand Test (STST)
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided. Not yet determined
Related trials for Heart Failure
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Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Active, not recruiting
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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.
Chris McIntyre, MBBS DM principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Levocarnitine in people with Heart Failure and Carnitine Deficiency, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathy Koyle (519-685-8500 ext. x 56214, kathleen.koyle@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From study start to end of study at 52 weeks). The study lists 5 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 20 Apr 2026.