NCT02433990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

4.1 years

First QC Date

May 13, 2014

Last Update Submit

September 17, 2019

Conditions

Congenital Heart Disease

Keywords

Congenital Heart DiseaseAcquired Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Risk factors for acquired cardiovascular disease in adults with congenital heart disease

    2 years

Study Arms (1)

Adult Congenital Heart Disease

18 years and older with congenital heart disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with Moderate or Complex Congenital Heart Disease

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 940304, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Susan Fernandes, PA-C, LP.D.

    Stanford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 5, 2015

Study Start

April 1, 2014

Primary Completion

April 24, 2018

Study Completion

August 24, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations

US(1)