Congenital Heart DefectsNCT00208754
Heart Failure in Adult Patients With a History of Congenital Heart Disease
An observational study of Congenital Heart Defects, run by Emory University at 1 site in United States.
Trial summary
In today's world of advanced surgery, children born with congenital heart disease (CHD) are surviving into adulthood. However, the surgical procedures these children undergo do not cure the underlying problem and this these children develop other heart problems later in life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Defects
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Dec 2005
- 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
Who may be able to join
- Adults who have a history of congenital heart defects
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Failure in Adult Patients With a History of Congenital Heart Disease.
In today's world of advanced surgery, children born with congenital heart disease (CHD) are surviving into adulthood. However, the surgical procedures these children undergo do not cure the underlying problem and this these children develop other heart problems later in life. Heart failure is the one of the most common heart problems effecting these patients. This heart failure can be seen in both lower pumping chambers of the heart, however, sometimes only one side of the heart is affected. Since there are several congenital heart defects that are now seen in the adult population, an understanding of what causes heart failure in this patient population can help physicians develop better treatments for this condition. The goal of this study is to review the medical records of 350 adult patients with congenital heart disease that has developed heart failure. During this review, we plan to collect information regarding the various treatments utilized in these patients and to determine if there are any common elements regarding the development of heart failure in adult patients with CHD.
Read the detailed description
In today's world of advanced surgery, children born with congenital heart disease (CHD) are surviving into adulthood. However, the surgical procedures these children undergo do not cure the underlying problem and this these children develop other heart problems later in life. Heart failure is the one of the most common heart problems effecting these patients. This heart failure can be seen in both lower pumping chambers of the heart, however, sometimes only one side of the heart is affected. Since there are several congenital heart defects that are now seen in the adult population, an understanding of what causes heart failure in this patient population can help physicians develop better treatments for this condition. The goal of this study is to review the medical records of 350 adult patients with congenital heart disease that has developed heart failure. During this review, we plan to collect information regarding the various treatments utilized in these patients and to determine if there are any common elements regarding the development of heart failure in adult patients with CHD.
- Conditions
- Congenital Heart Defects
- Keywords
- heart defects, cardiology, adults who have congenital heart defects
- Medical subject headings
- Heart Defects, Congenital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Emory 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
- Time perspective
- Retrospective
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy M. Book, Emory University
- Investigators
- Wendy Book, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208754
- Sponsor's protocol ID
- 0489-2004
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 13 Nov 2013
- Results posted
- No
Publications
Bolger AP, Coats AJ, Gatzoulis MA. Congenital heart disease: the original heart failure syndrome. Eur Heart J. 2003 May;24(10):970-6. doi: 10.1016/s0195-668x(03)00005-8.
PubMed 12714029Jessup M, Brozena S. Heart failure. N Engl J Med. 2003 May 15;348(20):2007-18. doi: 10.1056/NEJMra021498. No abstract available.
PubMed 12748317Packer M, Carver JR, Rodeheffer RJ, Ivanhoe RJ, DiBianco R, Zeldis SM, Hendrix GH, Bommer WJ, Elkayam U, Kukin ML, et al. Effect of oral milrinone on mortality in severe chronic heart failure. The PROMISE Study Research Group. N Engl J Med. 1991 Nov 21;325(21):1468-75. doi: 10.1056/NEJM199111213252103.
PubMed 1944425Deshpande RB, Deodhar LP. Ocular and orbital tumours and tumour-like lesions: a clinico-pathological study of 64 cases. J Postgrad Med. 1977 Apr;23(2):84-8. No abstract available.
PubMed 614419
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure in Adult Patients With a History of Congenital Heart Disease.
- ClinicalTrials.gov ID
- NCT00208754
- Acronym / sponsor ID
- 0489-2004
- Conditions
- Congenital Heart Defects
- Keywords
- heart defects, cardiology, adults who have congenital heart defects
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 350 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Dec 2005
- First posted
- 21 Sep 2005 (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.
In today's world of advanced surgery, children born with congenital heart disease (CHD) are surviving into adulthood. However, the surgical procedures these children undergo do not cure the underlying problem and this these children develop other heart problems later in life. Heart failure is the one of the most common heart problems effecting these patients. This heart failure can be seen in both lower pumping chambers of the heart, however, sometimes only one side of the heart is affected. Since there are several congenital heart defects that are now seen in the adult population, an understanding of what causes heart failure in this patient population can help physicians develop better treatments for this condition. The goal of this study is to review the medical records of 350 adult patients with congenital heart disease that has developed heart failure. During this review, we plan to collect information regarding the various treatments utilized in these patients and to determine if there are any common elements regarding the development of heart failure in adult patients with CHD.
Detailed description
In today's world of advanced surgery, children born with congenital heart disease (CHD) are surviving into adulthood. However, the surgical procedures these children undergo do not cure the underlying problem and this these children develop other heart problems later in life. Heart failure is the one of the most common heart problems effecting these patients. This heart failure can be seen in both lower pumping chambers of the heart, however, sometimes only one side of the heart is affected. Since there are several congenital heart defects that are now seen in the adult population, an understanding of what causes heart failure in this patient population can help physicians develop better treatments for this condition. The goal of this study is to review the medical records of 350 adult patients with congenital heart disease that has developed heart failure. During this review, we plan to collect information regarding the various treatments utilized in these patients and to determine if there are any common elements regarding the development of heart failure in adult patients with CHD.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults who have a history of congenital heart defects
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Background: PubMed 12714029Bolger AP, Coats AJ, Gatzoulis MA. Congenital heart disease: the original heart failure syndrome. Eur Heart J. 2003 May;24(10):970-6. doi: 10.1016/s0195-668x(03)00005-8.
- Background: PubMed 12748317Jessup M, Brozena S. Heart failure. N Engl J Med. 2003 May 15;348(20):2007-18. doi: 10.1056/NEJMra021498. No abstract available.
- Background: PubMed 1944425Packer M, Carver JR, Rodeheffer RJ, Ivanhoe RJ, DiBianco R, Zeldis SM, Hendrix GH, Bommer WJ, Elkayam U, Kukin ML, et al. Effect of oral milrinone on mortality in severe chronic heart failure. The PROMISE Study Research Group. N Engl J Med. 1991 Nov 21;325(21):1468-75. doi: 10.1056/NEJM199111213252103.
- Background: PubMed 614419Deshpande RB, Deodhar LP. Ocular and orbital tumours and tumour-like lesions: a clinico-pathological study of 64 cases. J Postgrad Med. 1977 Apr;23(2):84-8. No abstract available.
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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.
Wendy Book, MD principal investigator
Emory University
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 Defects, run by Emory 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 1 inclusion and 0 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 13 Nov 2013. 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 was stopped early. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00208754, which also lists 4 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 13 Nov 2013.