drugset / Trial / NCT02353312

Rhode Island Diastolic Dysfunction - Heart Failure

NCT02353312 ↗

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

EvaluationDrugModalityDoseRoute
Subject sapropterin Unknown 20 mg/kg Oral

Indications