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

NCT ID: NCT02433990

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2019-08-24

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.

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

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult Congenital Heart Disease

18 years and older with congenital heart disease

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Susan Fernandes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Fernandes, PA-C, LP.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford Hospital

Locations

Stanford Hospital and Clinics

Stanford, California, United States

Countries

United States

Other Identifiers

IRB-28847

Identifier Type: -

Identifier Source: org_study_id