Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

January 1, 2016

Primary Completion Date

June 1, 2016

Study Completion Date

December 31, 2019

Conditions
Rheumatologic Disease
Interventions
DRUG

BH4

BH4 10 mg/kg/day given once to a total of 12 SSc patients

DIAGNOSTIC_TEST

Vasculopathy assessment

Non-invasive technique, flow mediated dilatation (FMD) to define vasculopathy in SSc.

DRUG

Placebo

On the experimental days, patients reported to the laboratory after having consumed a standardized breakfast and oral BH4 (10mg/kg) or placebo five hours prior to their arrival. All measurements were taken at the same time of day to eliminate any diurnal effects. All participants abstained from alcohol, caffeine, and exercise for ≥12 hours prior to the study. Additionally, vasodilatory medications were discontinued 12 hours prior to study visit. In premenopausal women, measurements were performed during the early follicular phase of the menstrual cycle. All measurements were made under quiet, comfortable, ambient (\~22°C) laboratory conditions.

Trial Locations (1)

84148

VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT02530996 - Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment | Biotech Hunter | Biotech Hunter