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Aesculus Hippocastanum L. on Fontan Circulation

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ClinicalTrials.gov Identifier: NCT04035317
Recruitment Status : Withdrawn (The graduate student quit.)
First Posted : July 29, 2019
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Hospital das Clínicas de Ribeirão Preto
Information provided by (Responsible Party):
Fabio Carmona, Casa Espirita Terra de Ismael

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.

Condition or disease Intervention/treatment Phase
Univentricular Heart Drug: Aesculus Hippocastanum / Horse Chestnut Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients will be randomized to receive Aesculus hippocastanum or placebo for 4 months, followed by 4 weeks of washout and crossover.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The capsules will be identical in appearance and will be labelled only with patient's name.
Primary Purpose: Treatment
Official Title: Effect of Aesculus Hippocastanum L. (Sapindaceae, "Horse Chestnut") on Fontan Circulation - a Randomized Clinical Trial
Actual Study Start Date : October 31, 2017
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Mesenteric artery resistance [ Time Frame: After 4 months ]
    Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Underwent Fontan surgery

Exclusion Criteria:

  • Severe adverse reaction
  • Personal or parental request

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035317


Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Sponsors and Collaborators
Casa Espirita Terra de Ismael
Hospital das Clínicas de Ribeirão Preto
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Responsible Party: Fabio Carmona, MD, PhD, Casa Espirita Terra de Ismael
ClinicalTrials.gov Identifier: NCT04035317    
Other Study ID Numbers: CastanhaFontan
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021

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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
Keywords provided by Fabio Carmona, Casa Espirita Terra de Ismael:
Fontan operation
Aesculus hippocastanum
mesenteric artery resistance