Conditions: Isolated Systolic Hypertension Endothelial Dysfunction
Keywords: Isolated Systolic Hypertension with Endothelial Dysfunction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4 to improve endothelial function, reduce systolic blood pressure and reduce arterial stiffness.

Detailed description:
By comparing values measured at different timepoints, the study is expected to provide insight regarding the ability of 6R-BH4, administered along with their currently prescribed antihypertension medications, to improve endothelial function, reduce SBP, and reduce arterial stiffness in patients with ISH and endothelial dysfunction

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: 6R-BH4 intervention 2: Placebo
Intervention descriptions: intervention 1: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period intervention 2: placebo given BID for entire length of study

Protocol document: