NCT02552485

Brief Summary

Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 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

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

September 10, 2015

Last Update Submit

December 30, 2015

Conditions

Atrial Septal DefectsVentricular Septal Defects

Outcome Measures

Primary Outcomes (1)

  • Mortality

    From date of birth until date of study inclusion (up to 100 months)

Interventions

No intervention was applied, because it is an observational studyOTHER

Eligibility Criteria

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

Patients who underwent congenital heart defect closure before the age of 18 years and who are lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.

You may qualify if:

  • Previous repair for secundum ASD, VSD

You may not qualify if:

  • Other congenital heart disease
  • Chronic lung disease or total lung capacity \< 80% of predicted value
  • History of pulmonary embolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Heart Septal Defects, AtrialHeart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Werner Budts, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Werner Budts

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 17, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations

BE(1)