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

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT02433990
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Primary Completion: 2018-04-24
• Study Completion: 2019-08-24
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors for acquired cardiovascular disease in adults with congenital heart disease	2 years

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States