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Aesculus Hippocastanum L. on Fontan Circulation

Primary Purpose

Univentricular Heart

Status
Withdrawn
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Aesculus Hippocastanum / Horse Chestnut
Placebo
Sponsored by
Casa Espirita Terra de Ismael
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Univentricular Heart focused on measuring Fontan operation, Aesculus hippocastanum, mesenteric artery resistance

Eligibility Criteria

2 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Underwent Fontan surgery

Exclusion Criteria:

  • Severe adverse reaction
  • Personal or parental request

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aesculus hippocastanum

Placebo

Arm Description

Patients will receive extract of Aesculus hippocastanum

Patients will receive placebo

Outcomes

Primary Outcome Measures

Mesenteric artery resistance
Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units

Secondary Outcome Measures

Full Information

First Posted
July 23, 2019
Last Updated
January 26, 2021
Sponsor
Casa Espirita Terra de Ismael
Collaborators
Hospital das Clínicas de Ribeirão Preto
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1. Study Identification

Unique Protocol Identification Number
NCT04035317
Brief Title
Aesculus Hippocastanum L. on Fontan Circulation
Official Title
Effect of Aesculus Hippocastanum L. (Sapindaceae, "Horse Chestnut") on Fontan Circulation - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The graduate student quit.
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Casa Espirita Terra de Ismael
Collaborators
Hospital das Clínicas de Ribeirão Preto

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Univentricular Heart
Keywords
Fontan operation, Aesculus hippocastanum, mesenteric artery resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Patients will be randomized to receive Aesculus hippocastanum or placebo for 4 months, followed by 4 weeks of washout and crossover.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The capsules will be identical in appearance and will be labelled only with patient's name.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aesculus hippocastanum
Arm Type
Experimental
Arm Description
Patients will receive extract of Aesculus hippocastanum
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo
Intervention Type
Drug
Intervention Name(s)
Aesculus Hippocastanum / Horse Chestnut
Intervention Description
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
Primary Outcome Measure Information:
Title
Mesenteric artery resistance
Description
Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units
Time Frame
After 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Underwent Fontan surgery Exclusion Criteria: Severe adverse reaction Personal or parental request
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14048-900
Country
Brazil

12. IPD Sharing Statement

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Aesculus Hippocastanum L. on Fontan Circulation

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