NCT02353312
Heart Failure, Cardiovascular Disease
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.
To study the hypothesis that treating patients with underlying diastolic dysfunction with oral Kuvan® (BH4, also known as tetrahydrobiopterin) in addition to current best practices will improve metabolic and echocardiographic diastolic function parameters.
All
From 18 Years
No
Kuvan
Na
Interventional
28
2015-03
2019-01-30
Providence, Rhode Island, United States
1. Male and female U.S. Veteran patients over the age of eighteen, with echocardiographic findings of >= Grade 2 diastolic dysfunction [as per American Society of Echocardiography guidelines] and
2. Diagnosis of hypertension, diabetes, or heart failure in medical records.
3. Eligible subjects must be ambulatory (not dependent on any ambulatory assist devices including cane or walker).
1. Any history of documented ejection fraction <50% 2. Significant COPD (defined as oxygen-dependent COPD) 3. Acute coronary syndrome within the past three months defined by EKG changes and biomarkers of myocardial necrosis (ie. elevated troponin) in the setting of chest pain or an anginal equivalent) 4. Presence of hypertrophic cardiomyopathy 5. Presence of infiltrative/restrictive cardiomyopathy 6. Echocardiographic evidence of moderate or severe aortic or mitral valve stenosis or regurgitation 7. Previously diagnosed phenylketonuria 8. End stage renal disease requiring hemodialysis 9. Pre-existing seizure disorder 10. Terminal illness (not including heart failure) with expected survival of one year or less 11. Females who are pregnant or breastfeeding. All females of child bearing age will undergo pregnancy testing prior to randomization. 12. Recent hospitalization within three months. 13. Previous Bioprosthetic and/or mechanical aortic or mitral valve
By completing this form and clicking the send button, you understand and hereby consent to storage of your personal information, including within the United States and Europe, which will be accessible by BioMarin for purposes such as responding to your request, quality control, fulfilling compliance obligations, and assisting with products, services, or clinical trials. Depending on where you live, you may have the right to request access to, removal, or correction of your personal information held by BioMarin. You may submit your request via the contact information and/or webform located within the full BioMarin Privacy Policy.
*required fields
"*" indicates required fields