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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if carnitine supplements can help people with a type of high blood pressure affecting the lungs and heart by improving heart function. The study focuses on patients who often have heart issues due to fat buildup. By increasing carnitine levels, the treatment aims to help the heart use fats more effectively for energy. Carnitine has been shown to improve fat metabolism and has potential therapeutic benefits for cardiovascular disorders, including this type of high blood pressure.
Eligible Conditions
- Pulmonary Arterial Hypertension
- Lung Disease
- Pulmonary Hypertension
- Carnitine Deficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma Carnitine concentration
Secondary study objectives
Carnitine ingestion use through food
Echocardiography measurements of TAPSE and RV fractional area
Patient Reported Side Effects
+4 moreSide effects data
From 2021 Phase 2 & 3 trial • 144 Patients • NCT0178304125%
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
903 Previous Clinical Trials
938,566 Total Patients Enrolled
11 Trials studying Pulmonary Arterial Hypertension
2,526 Patients Enrolled for Pulmonary Arterial Hypertension
Anna R HemnesPrincipal InvestigatorVanderbilt University Medical Center
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