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Amino Acid

L-carnitine for Pulmonary Arterial Hypertension

Phase 1
Waitlist Available
Led By Anna R Hemnes
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
WHO Functional Class II-IV
Ambulatory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
No Placebo-Only Group

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
  • Pulmonary Hypertension
  • Carnitine Deficiency

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You experience symptoms that affect your daily activities and quality of life.
Select...
You are able to walk on your own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma Carnitine concentration
Secondary outcome measures
Carnitine ingestion use through food
Echocardiography measurements of TAPSE and RV fractional area
Patient Reported Side Effects
+4 more

Side effects data

From 2021 Phase 2 & 3 trial • 144 Patients • NCT01783041
25%
Patent ductus arteriosus
19%
Bronchopulmonary Dysplasia
6%
Blood culture positive sepsis
4%
Intraventricular hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
5% Dextrose
L-carnitine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SupplementExperimental Treatment1 Intervention
Form: 500 mg L-carnitine tablet Dosage: Subjects 50-90kg: 3g/day Subjects <50kg or >90kg: 50mg/kg/day Frequency: twice a day for 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-carnitine
2002
Completed Phase 4
~930

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
844 Previous Clinical Trials
668,528 Total Patients Enrolled
10 Trials studying Pulmonary Arterial Hypertension
2,485 Patients Enrolled for Pulmonary Arterial Hypertension
Anna R HemnesPrincipal InvestigatorVanderbilt University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~3 spots leftby Feb 2025