Heart Failure in Adult Patients With a History of Congeni... | NCT00208754

Studies
Heart Failure in Adult Patients With a History of Congenital Heart Disease

NCT00208754

Sponsor

Emory University

Status

Terminated

Last Update Posted

Nov 13, 2013Estimated

Enrollment

350

Phase

Not provided

Conditions

Congenital Heart Defects

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2013

Last Update Posted Date

Nov 13, 2013Estimated

Description Module

Brief 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. 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults who have a history of congenital heart defects

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wendy Book, MD	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University Hospital		Atlanta	Georgia	30322	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12714029	Background	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.
12748317	Background	Jessup M, Brozena S. Heart failure. N Engl J Med. 2003 May 15;348(20):2007-18. doi: 10.1056/NEJMra021498. No abstract available.

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities