Congenital Heart DiseaseNCT03470428
Clinical Characteristics and Associations of the "Good Fontan" Patient
An observational study of Congenital Heart Disease and Single-ventricle, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Congenital Heart Disease, Single-ventricle
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 18 Apr 2023
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with congenital heart disease who have undergone the Fontan procedure.
Who may be able to join
- Extracardiac or Lateral Funnel Fontan
Who cannot join
- Currently being evaluated for or listed for cardiac transplant
- Underwent Fontan revision or conversion
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients.
Read the detailed description
This is a multi-center prospective study that involves collecting data from patients as well as their cardiology providers in order to determine whether there is correlation between patient-reported quality of life assessments and clinician-identified assessments of their patients. The study also involves collecting data from the medical records of participating patients and entering it into our study database.
- Conditions
- Congenital Heart Disease, Single-ventricle
- Keywords
- Fontan, Single Ventricle
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Fontan Patients | Participants ages 10 to 18 who have had Lateral Tunnel or Extracardiac Fontan procedures. | |
| Adult Fontan Patients | Participants ages 18 to 60 who have had Lateral Tunnel or Extracardiac Fontan procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surprise question
The ability of the cardiologist's response to the "surprise" question to predict adverse cardiac events within 1 year
Measured: 1 year
Secondary outcomes (3)
Clinical characteristics and associations of the "good Fontan"
Clinical characteristics and associations of this group (the "good Fontan") are different compared to those that are in the "at-risk" category (all others that do not fit into the "good Fontan" category). Data measurements will include relevant clinical data available for each patient, including but not limited to data from cardiac surgeries, catheterizations, MRIs, echocardiograms, exercise stress tests, current medications, labs, and patient responses to questionnaires.
Measured: 1 year
Correlation between patient and provider assessments
There will be a positive correlation of the patient's own assessment of quality of life with the clinician-identified designation of a "good Fontan."
Measured: 1 year
Clinician factors associated with adverse events conversation with patients
Clinician factors (years of experience, primary subspecialty, gender, parenthood) are associated with beliefs in regard to appropriate timing to discuss potential long-term adverse events to Fontan patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start5 Mar 2018
- Primary completion20 Mar 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- New England Congenital Cardiology Association (NECCA), Yale University, Dartmouth College, Connecticut Children's Medical Center, University of Vermont, Child Heart Associates, Congenital Heart, University of Massachusetts, Worcester, Massachusetts General Hospital
- Responsible party
- Principal investigator, Rahul Rathod, Boston Children's Hospital
- Investigators
- Rahul Rathod, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470428
- Sponsor's protocol ID
- IRB-P00024716
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2018
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
d'Udekem Y, Iyengar AJ, Cochrane AD, Grigg LE, Ramsay JM, Wheaton GR, Penny DJ, Brizard CP. The Fontan procedure: contemporary techniques have improved long-term outcomes. Circulation. 2007 Sep 11;116(11 Suppl):I157-64. doi: 10.1161/CIRCULATIONAHA.106.676445.
PubMed 17846297Diller GP, Giardini A, Dimopoulos K, Gargiulo G, Muller J, Derrick G, Giannakoulas G, Khambadkone S, Lammers AE, Picchio FM, Gatzoulis MA, Hager A. Predictors of morbidity and mortality in contemporary Fontan patients: results from a multicenter study including cardiopulmonary exercise testing in 321 patients. Eur Heart J. 2010 Dec;31(24):3073-83. doi: 10.1093/eurheartj/ehq356. Epub 2010 Oct 7.
PubMed 20929979Blume ED, Balkin EM, Aiyagari R, Ziniel S, Beke DM, Thiagarajan R, Taylor L, Kulik T, Pituch K, Wolfe J. Parental perspectives on suffering and quality of life at end-of-life in children with advanced heart disease: an exploratory study*. Pediatr Crit Care Med. 2014 May;15(4):336-42. doi: 10.1097/PCC.0000000000000072.
PubMed 24583501Lakin JR, Robinson MG, Bernacki RE, Powers BW, Block SD, Cunningham R, Obermeyer Z. Estimating 1-Year Mortality for High-Risk Primary Care Patients Using the "Surprise" Question. JAMA Intern Med. 2016 Dec 1;176(12):1863-1865. doi: 10.1001/jamainternmed.2016.5928. No abstract available.
PubMed 27695853Hamano J, Morita T, Inoue S, Ikenaga M, Matsumoto Y, Sekine R, Yamaguchi T, Hirohashi T, Tajima T, Tatara R, Watanabe H, Otani H, Takigawa C, Matsuda Y, Nagaoka H, Mori M, Yamamoto N, Shimizu M, Sasara T, Kinoshita H. Surprise Questions for Survival Prediction in Patients With Advanced Cancer: A Multicenter Prospective Cohort Study. Oncologist. 2015 Jul;20(7):839-44. doi: 10.1634/theoncologist.2015-0015. Epub 2015 Jun 8.
PubMed 26054631
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Associations of the "Good Fontan" Patient
- ClinicalTrials.gov ID
- NCT03470428
- Acronym / sponsor ID
- IRB-P00024716
- Conditions
- Congenital Heart Disease, Single-ventricle
- Keywords
- Fontan, Single Ventricle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- New England Congenital Cardiology Association (NECCA), Yale University, Dartmouth College, Connecticut Children's Medical Center, University of Vermont, Child Heart Associates, Congenital Heart, University of Massachusetts, Worcester, Massachusetts General Hospital
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 20 Mar 2018 (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 study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients.
Detailed description
This is a multi-center prospective study that involves collecting data from patients as well as their cardiology providers in order to determine whether there is correlation between patient-reported quality of life assessments and clinician-identified assessments of their patients. The study also involves collecting data from the medical records of participating patients and entering it into our study database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Fontan Patients | – | –Participants ages 10 to 18 who have had Lateral Tunnel or Extracardiac Fontan procedures. |
| Adult Fontan Patients | – | –Participants ages 18 to 60 who have had Lateral Tunnel or Extracardiac Fontan procedures. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with congenital heart disease who have undergone the Fontan procedure.
Key inclusion criteria (1 listed)
- Extracardiac or Lateral Funnel Fontan
Key exclusion criteria (3 listed)
- Currently being evaluated for or listed for cardiac transplant
- Underwent Fontan revision or conversion
- Currently pregnant
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
Surprise question
Time frame: 1 year
The ability of the cardiologist's response to the "surprise" question to predict adverse cardiac events within 1 year
3 secondary outcomes
Clinical characteristics and associations of the "good Fontan"
Time frame: 1 year
Correlation between patient and provider assessments
Time frame: 1 year
Clinician factors associated with adverse events conversation with patients
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 17846297d'Udekem Y, Iyengar AJ, Cochrane AD, Grigg LE, Ramsay JM, Wheaton GR, Penny DJ, Brizard CP. The Fontan procedure: contemporary techniques have improved long-term outcomes. Circulation. 2007 Sep 11;116(11 Suppl):I157-64. doi: 10.1161/CIRCULATIONAHA.106.676445.
- Background: PubMed 20929979Diller GP, Giardini A, Dimopoulos K, Gargiulo G, Muller J, Derrick G, Giannakoulas G, Khambadkone S, Lammers AE, Picchio FM, Gatzoulis MA, Hager A. Predictors of morbidity and mortality in contemporary Fontan patients: results from a multicenter study including cardiopulmonary exercise testing in 321 patients. Eur Heart J. 2010 Dec;31(24):3073-83. doi: 10.1093/eurheartj/ehq356. Epub 2010 Oct 7.
- Background: PubMed 24583501Blume ED, Balkin EM, Aiyagari R, Ziniel S, Beke DM, Thiagarajan R, Taylor L, Kulik T, Pituch K, Wolfe J. Parental perspectives on suffering and quality of life at end-of-life in children with advanced heart disease: an exploratory study*. Pediatr Crit Care Med. 2014 May;15(4):336-42. doi: 10.1097/PCC.0000000000000072.
- Background: PubMed 27695853Lakin JR, Robinson MG, Bernacki RE, Powers BW, Block SD, Cunningham R, Obermeyer Z. Estimating 1-Year Mortality for High-Risk Primary Care Patients Using the "Surprise" Question. JAMA Intern Med. 2016 Dec 1;176(12):1863-1865. doi: 10.1001/jamainternmed.2016.5928. No abstract available.
- Background: PubMed 26054631Hamano J, Morita T, Inoue S, Ikenaga M, Matsumoto Y, Sekine R, Yamaguchi T, Hirohashi T, Tajima T, Tatara R, Watanabe H, Otani H, Takigawa C, Matsuda Y, Nagaoka H, Mori M, Yamamoto N, Shimizu M, Sasara T, Kinoshita H. Surprise Questions for Survival Prediction in Patients With Advanced Cancer: A Multicenter Prospective Cohort Study. Oncologist. 2015 Jul;20(7):839-44. doi: 10.1634/theoncologist.2015-0015. Epub 2015 Jun 8.
- 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.
Rahul Rathod, MD principal investigator
Boston Children's Hospital
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 Congenital Heart Disease and Single-ventricle, run by Boston Children's Hospital at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 19 Apr 2023. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surprise question (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470428, which also lists 5 linked publications.
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 19 Apr 2023.