Aesculus Hippocastanum L. on Fontan Circulation

Casa Espirita Terra de Ismael

Status and phase: Withdrawn; Phase 2

Conditions: Univentricular Heart

Treatments: Drug: Placebo; Drug: Aesculus Hippocastanum / Horse Chestnut

Study type: Interventional

Funder types: Other

Identifiers

NCT04035317

CastanhaFontan

Details and patient eligibility

About

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.

Sex: All

Ages: 2 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Underwent Fontan surgery

Exclusion criteria

• Severe adverse reaction
• Personal or parental request

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Aesculus hippocastanum

Experimental group

Description:

Patients will receive extract of Aesculus hippocastanum

Treatment:

Drug: Aesculus Hippocastanum / Horse Chestnut

Placebo

Placebo Comparator group

Description:

Patients will receive placebo

Treatment:

Drug: Placebo