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Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT02433990
Recruitment Status : Unknown
Verified April 2017 by Susan Fernandes, Stanford University.
Recruitment status was:  Enrolling by invitation
First Posted : May 5, 2015
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Susan Fernandes, Stanford University

Brief 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease
Study Start Date : April 2014
Estimated Primary Completion Date : June 1, 2017
Estimated Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort
Adult Congenital Heart Disease
18 years and older with congenital heart disease



Primary Outcome Measures :
  1. Risk factors for acquired cardiovascular disease in adults with congenital heart disease [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with Moderate or Complex Congenital Heart Disease
Criteria

Inclusion Criteria:

  • Male or Female over 18 years of age
  • Moderate or Complex Congenital Heart Disease
  • Willingness to Consent

Exclusion Criteria:

  • Pregnancy
  • Surgery within 6 months
  • Unrepaired cyanotic heart disease
  • Patients with Eisenmenger Syndrome physiology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433990


Locations
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United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 940304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Susan Fernandes, PA-C, LP.D. Stanford Hospital

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Responsible Party: Susan Fernandes, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02433990     History of Changes
Other Study ID Numbers: IRB-28847
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: April 2017

Keywords provided by Susan Fernandes, Stanford University:
Congenital Heart Disease
Acquired Cardiovascular Disease

Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities