Status:
WITHDRAWN
O2 Transport and Utilization in Health and Lung Disease
Lead Sponsor:
University of Massachusetts, Amherst
Conditions:
COPD
Tetrahydrobiopterin Deficiency
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
Skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of Chronic Pulmonary Obstructive Disease (COPD), which is still poorly understood. Therefore, the focus of this...
Detailed Description
The purpose of this study is to assess the efficacy of supplementation with tetrahydrobiopterin (BH4) for improving vascular and muscle function in patients with COPD and healthy controls.
Eligibility Criteria
Inclusion
- All subjects must be between the age of 18 and 85 years;
- For the COPD cohort, patients with a diagnosis of stable COPD (i.e., those not experiencing an acute exacerbation of symptoms) and spirometric evidence of airway obstruction (FEV1 \<80% predicted, FEV/FVC\<0.70);
- Ability to perform motor tests;
- Ability to provide informed consent
Exclusion
- uncontrolled hypertension;
- hyperlipidemia;
- recent exacerbation;
- Major cardiovascular event procedure (\<3 months);
- Pregnancy
- known significant hepatic, renal disease, active substance abuse
- contraindication to MRI, claustrophobia
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04014712
Start Date
April 1 2021
End Date
August 1 2022
Last Update
December 19 2023
Active Locations (1)
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1
Institute of Applied Life Sciences
Amherst, Massachusetts, United States, 01003