Effect of Aesculus Hippocastanum L. (Sapindaceae, "Horse Chestnut") on Fontan Circulation - a Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Mesenteric artery resistance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The capsules will be identical in appearance and will be labelled only with patient's name.
Eligibility Criteria
- Ages
- 2 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Underwent Fontan surgery
Exclusion Criteria
- •Severe adverse reaction
- •Personal or parental request
Arms & Interventions
Aesculus hippocastanum
Patients will receive extract of Aesculus hippocastanum
Intervention: Aesculus Hippocastanum / Horse Chestnut (Drug)
Placebo
Patients will receive placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Mesenteric artery resistance
Time Frame: After 4 months
Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units
Secondary Outcomes
No secondary outcomes reported
Investigators
Fabio Carmona
MD, PhD
Casa Espirita Terra de Ismael