drugset / Trial / NCT02353312
Rhode Island Diastolic Dysfunction - Heart Failure
Completed
28 enrolled
Providence VA Medical Center
BioMarin Pharmaceutical · collabLifespan · collab
RandomizedCrossoverOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2015-03
- Primary completion
- 2018-12
- Completion
- 2018-12
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (equivalence test); On Kuvan vs Not on Kuvan; p = 0.823; t-test, 2 sided NCT02353312 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sapropterin | Unknown | 20 mg/kg | Oral |