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Aesculus Hippocastanum L. on Fontan Circulation

NCT04035317 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-01-28

No results posted yet for this study

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.

Conditions

  • Univentricular Heart

Interventions

DRUG

Aesculus Hippocastanum / Horse Chestnut

Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.

DRUG

Placebo

Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.

Sponsors & Collaborators

  • Hospital das Clínicas de Ribeirão Preto

    collaborator OTHER

  • Casa Espirita Terra de Ismael

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035317 on ClinicalTrials.gov