Oral Carnitine in Heart Failure Patients

NCT07201714 | Recruiting Early Phase 1

• 1 other identifier: 16078
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure; Carnitine Deficiency

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  % of eligible patients enrolled over the study period

  From study start to end of study at 52 weeks

• Retention Rate

  % of enrolled participants completing final follow up

  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.

  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.

  From enrollment to end of treatment at 6 months

• Data Completeness

  % of participants with complete data for each outcome

  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)

  From enrollment to the end of treatment at 6 months.

• Change in cognitive function (Montreal Cognitive Assessment (MoCA))

  From enrollment to the end of treatment at 6 months.

• Change in cognitive function (Creyos)

  From enrollment to the end of treatment at 6 months.

• Change in Patient Reported Outcome Measurements (PROM) using Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  From enrollment to the end of treatment at 6 months.

• Change in Cardiac Function (Echocardiogram)

  From enrollment to the end of treatment at 6 months.

Other Outcomes (2)

• Change in serum biomarkers

  From enrolment to the end of treatment at 6 months.

• Change in urine biomarkers

  From enrolment to the end of treatment at 6 months.

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: Levocarnitine

Interventions

Levocarnitine DRUG

Oral L-carnitine, 2970mg daily (950mg, to be taken 3 times a day) for 3 months.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure; Systemic carnitine deficiency

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Chris McIntyre, MBBS DM

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Koyle

CONTACT

519-685-8500; kathleen.koyle@lhsc.on.ca

Amy Freeman, RN

CONTACT

519-685-8500; amy.freeman@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Model Details: Prospective, interventional, pilot study

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: October 1, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CA (1)