Hypoplastic Left Heart SyndromeHLHSNCT05709275
Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation
An observational study of Hypoplastic Left Heart Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
This project has several objectives ranging from clinical data analysis to computational simulations as listed below: 1. Retrospective review of all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to assess the SEVR after each step of Norwood palliation to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoplastic Left Heart Syndrome
- How many people
- 6 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jul 2022to 30 Sep 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato
Who may be able to join
- Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato.
Who cannot join
- Patients with any type of atrioventricular discordance.
- Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato before March 2019.
Trial locations and contacts
1 site in 1 country.
About this study
This project has several objectives ranging from clinical data analysis to computational simulations as listed below:
- Retrospective review of all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to assess the SEVR after each step of Norwood palliation to analyze its influences on:
- Mortality;
- Occurrence of adverse events;
- Outcome of the three-staged palliation;
- Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.
- Conditions
- Hypoplastic Left Heart Syndrome
- Medical subject headings
- Hypoplastic Left Heart Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality during the hospital stay and after the discharge
death, cardiovascular arrest
Measured: 5 year
Secondary outcomes (1)
Number of adverse events registered during the follow-up.
Patients will be followed prospectively with their normal routine cardiological follow-up for 5 years
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start28 Jul 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Why it stopped: early suspension of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoplastic Left Heart SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Saracino, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709275
- Sponsor's protocol ID
- HLHS
- Acronym
- HLHS
- Status last verified
- Oct 2024
- First submitted
- 10 Jan 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation
- ClinicalTrials.gov ID
- NCT05709275
- Acronym / sponsor ID
- HLHS / HLHS
- Conditions
- Hypoplastic Left Heart Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: early suspension of the study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 2 Feb 2023 (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.
This project has several objectives ranging from clinical data analysis to computational simulations as listed below:
- Retrospective review of all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to assess the SEVR after each step of Norwood palliation to analyze its influences on:
- Mortality;
- Occurrence of adverse events;
- Outcome of the three-staged palliation;
- Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato
Key inclusion criteria (1 listed)
- Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato.
Key exclusion criteria (2 listed)
- Patients with any type of atrioventricular discordance.
- Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato before March 2019.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality during the hospital stay and after the discharge
Time frame: 5 year
death, cardiovascular arrest
1 secondary outcome
Number of adverse events registered during the follow-up.
Time frame: 5 year
Results and safety
The study was stopped early (reason given: early suspension of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Hypoplastic Left Heart Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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: stopped early, as of the sponsor's last update on 21 Oct 2024. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: early suspension of the study). Results are not available in the source record.
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?
Mortality during the hospital stay and after the discharge (time frame: 5 year). 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 21 Oct 2024.