Univentricular HeartPhase 2NCT04035317
Aesculus Hippocastanum L. on Fontan Circulation
A Phase 2 study testing Aesculus Hippocastanum / Horse Chestnut in people with Univentricular Heart, run by Casa Espirita Terra de Ismael at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 40 years
- Conditions the study is for
- Univentricular Heart
- What is being tested?
- Aesculus Hippocastanum / Horse Chestnut
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Oct 2017to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Underwent Fontan surgery
Who cannot join
- Severe adverse reaction
- Personal or parental request
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: 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.
- Conditions
- Univentricular Heart
- Being tested
- Aesculus Hippocastanum / Horse Chestnut, Placebo
- Keywords
- Fontan operation, Aesculus hippocastanum, mesenteric artery resistance
- Medical subject headings
- Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aesculus Hippocastanum / Horse ChestnutDrug
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
PlaceboDrug
Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Aesculus hippocastanum | Experimental | Patients will receive extract of Aesculus hippocastanum Receives: Drug: Aesculus Hippocastanum / Horse Chestnut |
| Placebo | Placebo comparator | Patients will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesenteric artery resistance
Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units
Measured: After 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start31 Oct 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: The graduate student quit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Univentricular HeartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa Espirita Terra de Ismael
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto
- Responsible party
- Principal investigator, Fabio Carmona, Casa Espirita Terra de Ismael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035317
- Sponsor's protocol ID
- CastanhaFontan
- Status last verified
- Jan 2021
- First submitted
- 23 Jul 2019
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aesculus Hippocastanum L. (Sapindaceae, "Horse Chestnut") on Fontan Circulation - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04035317
- Acronym / sponsor ID
- CastanhaFontan
- Conditions
- Univentricular Heart
- Keywords
- Fontan operation, Aesculus hippocastanum, mesenteric artery resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The graduate student quit.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Casa Espirita Terra de IsmaelUniversity, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive Aesculus hippocastanum or placebo for 4 months, followed by 4 weeks of washout and crossover.
| Arm | Type | Receives |
|---|---|---|
| Aesculus hippocastanum | Experimental | Drug: Aesculus Hippocastanum / Horse ChestnutPatients will receive extract of Aesculus hippocastanum |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Underwent Fontan surgery
Key exclusion criteria (2 listed)
- Severe adverse reaction
- Personal or parental request
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aesculus Hippocastanum / Horse ChestnutTreatment for 4 months, washout of 4 weeks, then crossover for another 4 months. | Drug | Aesculus hippocastanum |
| PlaceboTreatment for 4 months, washout of 4 weeks, then crossover for another 4 months. | Drug | Placebo |
Primary outcome
Mesenteric artery resistance
Time frame: After 4 months
Mesenteric artery resistance, measured by pulsed-wave Doppler, in 0.1 units
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aesculus Hippocastanum / Horse Chestnut in people with Univentricular Heart, run by Casa Espirita Terra de Ismael at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesenteric artery resistance (time frame: After 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.