Status:
COMPLETED
Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
In preparation for a future mechanistic study, investigators now propose to test the specific hypothesis that carnitine consumption is not reduced in PAH, that plasma carnitine levels are stable over ...
Detailed Description
Right ventricular (RV) failure is the most common cause of death in pulmonary arterial hypertension (PAH). No RV-specific therapies are available, in part because the underlying mechanisms of RV failu...
Eligibility Criteria
Inclusion
- Adults aged 18 or older.
- Diagnosed with idiopathic, heritable, simple congenital heart defect, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
- Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
- FEV1\> or = 60% predicted and no more than mild abnormalities on lung imaging
- WHO Functional Class II-IV
- Ambulatory
Exclusion
- Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity
- Pregnancy
- Diagnosis of PAH etiology other than idiopathic, heritable, simple congenital heart defect, or associated with drugs or toxins
- Drug and toxin associated PAH patients with active drug use
- Prior diagnosis of cirrhosis
- Malignancy
- eGFR by MDRD \<60mL/min
- Known allergy to l-carnitine supplements
Key Trial Info
Start Date :
September 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04908397
Start Date
September 29 2021
End Date
June 30 2023
Last Update
September 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232