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NCT04035317 Clinical Trial

Aesculus Hippocastanum L. on Fontan Circulation

Univentricular Heart Clinical Trial

Official title:
Effect of Aesculus Hippocastanum L. (Sapindaceae, "Horse Chestnut") on Fontan Circulation - a Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04035317
Other study ID # CastanhaFontan
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date October 31, 2017
Est. completion date December 31, 2020

Study information
Verified date January 2021
Source Casa Espirita Terra de Ismael
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 2 Years to 40 Years
Eligibility Inclusion Criteria: - Underwent Fontan surgery Exclusion Criteria: - Severe adverse reaction - Personal or parental request

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aesculus Hippocastanum / Horse Chestnut
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
• Placebo
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.

Locations
Country Name City State
Brazil Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Ribeirão Preto Sao Paulo

Sponsors (2)
Lead Sponsor Collaborator
Casa Espirita Terra de Ismael Hospital das Clínicas de Ribeirão Preto

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mesenteric artery resistance Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units After 4 months
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