Aesculus Hippocastanum L. on Fontan Circulation

January 26, 2021 updated by: Fabio Carmona, Casa Espirita Terra de Ismael

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Ribeirão Preto, Sao Paulo, Brazil, 14048-900
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Underwent Fontan surgery

Exclusion Criteria:

  • Severe adverse reaction
  • Personal or parental request

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aesculus hippocastanum
Patients will receive extract of Aesculus hippocastanum
Drug: Aesculus Hippocastanum / Horse Chestnut
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
Placebo Comparator: Placebo
Patients will receive placebo
Drug: Placebo
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mesenteric artery resistance
Time Frame: After 4 months
Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units
After 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa Espirita Terra de Ismael

Collaborators

Hospital das Clínicas de Ribeirão Preto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CastanhaFontan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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