L-carnitine for Pulmonary Arterial Hypertension

Phase-Based Progress Estimates
Vanderbilt University Medical Center, Nashville, TNPulmonary Arterial Hypertension+10 MoreL-carnitine - DietarySupplement
18 - 85
All Sexes
What conditions do you have?

Study Summary

This trial is testing the hypothesis that carnitine supplementation can improve RV function in PAH patients by measuring the oral consumption of carnitine, the stability of plasma carnitine levels, and the effects of carnitine supplementation on RV function.

Eligible Conditions
  • Pulmonary Arterial Hypertension
  • Lung Disease
  • Familial Primary Pulmonary Hypertension
  • Primary Pulmonary Hypertension
  • Carnitine Deficiency

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 14 weeks

12 weeks
Carnitine ingestion use through food
Prevalence of Carnitine supplement use
Stability of plasma carnitine
14 weeks
Echocardiography measurements of TAPSE and RV fractional area
Plasma Carnitine concentration
Six-minute walk
WHO functional class
2 weeks
Patient Reported Side Effects

Trial Safety

Side Effects for

5% Dextrose
25%Patent ductus arteriosus
19%Bronchopulmonary Dysplasia
6%Blood culture positive sepsis
4%Intraventricular hemorrhage
This histogram enumerates side effects from a completed 2021 Phase 2 & 3 trial (NCT01783041) in the 5% Dextrose ARM group. Side effects include: Patent ductus arteriosus with 25%, Bronchopulmonary Dysplasia with 19%, Blood culture positive sepsis with 6%, Intraventricular hemorrhage with 4%.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: L-carnitine · No Placebo Group · Phase 1

Experimental Group · 1 Intervention: L-carnitine · Intervention Types: DietarySupplement
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 14 weeks

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
784 Previous Clinical Trials
599,316 Total Patients Enrolled
9 Trials studying Pulmonary Arterial Hypertension
2,501 Patients Enrolled for Pulmonary Arterial Hypertension
Anna R HemnesPrincipal InvestigatorVanderbilt University Medical Center

Eligibility Criteria

Age 18 - 85 · All Participants · 6 Total Inclusion Criteria

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Frequently Asked Questions

Has L-carnitine been granted authorization by the Food and Drug Administration?

"While data exists to suggest that L-carnitine is effective and safe, due to this being a Phase 1 trial we have given it the lowest possible rating of '1' on our scale." - Anonymous Online Contributor

Unverified Answer

What is the upper bound on enrollment for this medical experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this medical experiment, which went public on September 29th 2021 is actively asking for volunteers. A total of 12 individuals will be chosen from a single location for participation in the trial." - Anonymous Online Contributor

Unverified Answer

Is there an age limit for individuals wishing to participate in the research trial?

"As stated in the study's eligibility requirements, individuals aged 18 to 85 are able to enroll." - Anonymous Online Contributor

Unverified Answer

Are they admitting new participants in this experiment?

"As stated on clinicaltrials.gov, this medical experiment is currently recruiting participants. It was first made available on September 29th 2021 and the most recent modifications to it took place on August 30th 2022." - Anonymous Online Contributor

Unverified Answer

Is it possible to enlist as a participant in this trial?

"This trial is seeking 12 volunteers who are aged 18 to 85, have a diagnosis of lung disease and meet some essential criteria. These include: (1) having been on a stable PAH-specific medication regime for 3 months; (2) no more than one adjustment in diuretics within the same time period; (3) IV prostacyclin readjustment permissible if side effects occur; (4) ambulatory ability and WHO Functional Class II-IV status." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.