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NCT02433990 Clinical Trial

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

Congenital Heart Disease Clinical Trial

Official title:
Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02433990
Other study ID # IRB-28847
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date August 24, 2019

Study information
Verified date September 2019
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date August 24, 2019
Est. primary completion date April 24, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Stanford Hospital and Clinics Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Risk factors for acquired cardiovascular disease in adults with congenital heart disease 2 years
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