NCT04035317

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

July 23, 2019

Last Update Submit

January 26, 2021

Conditions

Univentricular Heart

Keywords

Fontan operationAesculus hippocastanummesenteric artery resistance

Outcome Measures

Primary Outcomes (1)

  • Mesenteric artery resistance

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

    After 4 months

Study Arms (2)

Aesculus hippocastanum

EXPERIMENTAL

Patients will receive extract of Aesculus hippocastanum

Drug: Aesculus Hippocastanum / Horse Chestnut

Placebo

PLACEBO COMPARATOR

Patients will receive placebo

Drug: Placebo

Interventions

Aesculus Hippocastanum / Horse ChestnutDRUG

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

Aesculus hippocastanum
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age2 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Underwent Fontan surgery

You may not qualify if:

  • Severe adverse reaction
  • Personal or parental request

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

MeSH Terms

Conditions

Univentricular Heart

Interventions

horse chestnut seed

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The capsules will be identical in appearance and will be labelled only with patient's name.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Patients will be randomized to receive Aesculus hippocastanum or placebo for 4 months, followed by 4 weeks of washout and crossover.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 29, 2019

Study Start

October 31, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

BR(1)