Aesculus Hippocastanum L. on Fontan Circulation

Phase 2

Withdrawn

• Conditions: Univentricular Heart
• Interventions: Drug: Aesculus Hippocastanum / Horse Chestnut; Drug: Placebo

• Registration Number: NCT04035317
• Lead Sponsor: Casa Espirita Terra de Ismael

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-31
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Underwent Fontan surgery

Exclusion Criteria

• Severe adverse reaction
• Personal or parental request

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aesculus hippocastanum	Aesculus Hippocastanum / Horse Chestnut	Patients will receive extract of Aesculus hippocastanum
Placebo	Placebo	Patients will receive placebo

Primary Outcome Measures

Name	Time	Method
Mesenteric artery resistance	After 4 months	Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; 🇧🇷 Ribeirão Preto, Sao Paulo, Brazil