Congenital Heart DiseaseNCT02433990
Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Stanford University at 1 site in United States.
Trial summary
This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 24 Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Moderate or Complex Congenital Heart Disease
Who may be able to join
- Male or Female over 18 years of age
- Moderate or Complex Congenital Heart Disease
- Willingness to Consent
Who cannot join
- Pregnancy
- Surgery within 6 months
- Unrepaired cyanotic heart disease
- Patients with Eisenmenger Syndrome physiology
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 940304
About this study
This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.
Read the detailed description
Advances in surgical and clinical management of patients with congenital heart disease has made survival to adulthood an expectation. Today there are more than 1 million adult survivors of congenital heart disease, but increasing age brings additional concerns for this patient population. Although the literature remains scarce, existing evidence suggests that inactivity, obesity, diabetes, cancer, and acquired cardiovascular disease may be at least as prevalent in patients with congenital heart disease, if not more so, than in an age-matched general population. Acquired cardiovascular disease is likely to impact substantially on long-term survival and quality of life in these patients with palliated and already fragile hearts. This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital Heart Disease, Acquired Cardiovascular Disease
- Medical subject headings
- Heart Defects, Congenital
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 |
|---|---|---|
| Adult Congenital Heart Disease | 18 years and older with congenital heart disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for acquired cardiovascular disease in adults with congenital heart disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2014
- Primary completion24 Apr 2018
- Study completion24 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Fernandes, Stanford University
- Investigators
- Susan Fernandes, PA-C, LP.D., Principal investigator, Stanford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433990
- Sponsor's protocol ID
- IRB-28847
- Status last verified
- Sep 2019
- First submitted
- 13 May 2014
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02433990
- Acronym / sponsor ID
- IRB-28847
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital Heart Disease, Acquired Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Aug 2019 (actual)
- First posted
- 5 May 2015 (estimated)
- 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 research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.
Detailed description
Advances in surgical and clinical management of patients with congenital heart disease has made survival to adulthood an expectation. Today there are more than 1 million adult survivors of congenital heart disease, but increasing age brings additional concerns for this patient population. Although the literature remains scarce, existing evidence suggests that inactivity, obesity, diabetes, cancer, and acquired cardiovascular disease may be at least as prevalent in patients with congenital heart disease, if not more so, than in an age-matched general population. Acquired cardiovascular disease is likely to impact substantially on long-term survival and quality of life in these patients with palliated and already fragile hearts. This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Congenital Heart Disease | – | –18 years and older with congenital heart disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Moderate or Complex Congenital Heart Disease
Key inclusion criteria (3 listed)
- Male or Female over 18 years of age
- Moderate or Complex Congenital Heart Disease
- Willingness to Consent
Key exclusion criteria (4 listed)
- Pregnancy
- Surgery within 6 months
- Unrepaired cyanotic heart disease
- Patients with Eisenmenger Syndrome physiology
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
Risk factors for acquired cardiovascular disease in adults with congenital heart disease
Time frame: 2 years
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 18 Sep 2019.
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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.
Susan Fernandes, PA-C, LP.D. principal investigator
Stanford 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, run by Stanford University 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 3 inclusion and 4 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 18 Sep 2019. 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?
Risk factors for acquired cardiovascular disease in adults with congenital heart disease (time frame: 2 years). 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 18 Sep 2019.