Univentricular Heart
Conditions
Keywords
Fontan operation, Aesculus hippocastanum, mesenteric artery resistance
Brief summary
Patients after the Fontan operation at a single institution will be randomized to receive a standardized extract of Aesculus hippocastanum L. (horse chestnut) or placebo for 4 months in a crossover clinical trial. The primary outcome will be the mesenteric artery resistance measured by Dopple sonography.
Interventions
DRUGAesculus Hippocastanum / Horse Chestnut
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
DRUGPlacebo
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
Sponsors
Hospital das Clínicas de Ribeirão Preto
Casa Espirita Terra de Ismael
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The capsules will be identical in appearance and will be labelled only with patient's name.
Intervention model description
Patients will be randomized to receive Aesculus hippocastanum or placebo for 4 months, followed by 4 weeks of washout and crossover.
Eligibility
Sex/Gender
ALL
Age
2 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Underwent Fontan surgery
Exclusion criteria
* Severe adverse reaction * Personal or parental request
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mesenteric artery resistance | After 4 months | Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units |
Countries
Brazil
Outcome results
None listed