NCT03642405

Drug-induced Repolarization ECG Changes

Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Studies have shown that the risk of developing heart arrhythmias, is increased in patients receiving medication for Attention-deficit hyperactivity disorder (ADHD) and depression. The QT-interval on a electrocardiogram (ECG) is often used to assess the patients risk of developing heart arrhythmias. The QT-interval defines the hearts electrical resting period and a long interval is linked to an increased risk of developing heart arrhythmias. In this project the investigators wish to examine possible side-effects in patients receiving medication for ADHD and depression and their dynamic QT-interval changes, by analysing the ECG changes that occur during "Brisk Standing".

Conditions

• Long QT Syndrome
• ADHD
• Depression
• Death
• Death, Sudden, Cardiac
• Romano-Ward Syndrome
• Pathologic Processes
• Heart Arrest
• Electrocardiogram: Electrical Alternans
• Heart Diseases
• Cardiovascular Diseases
• Death, Sudden
• Arrhythmias, Cardiac
• Heart Defects, Congenital
• Cardiovascular Abnormalities
• Congenital Abnormalities
• Genetic Disease
• Genetic Syndrome
• Qt Interval, Variation in
• Psychiatric Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Electrocardiogram examination	12-lead ECG monitored by Holter
DIAGNOSTIC_TEST	Echocardiography	Echocardiography in accordance to Danish Society of Cardiology
PROCEDURE	Blood Samples	Blood Samples include, Genetic analysis, serum-Methylphenidate, serum-Citalopram. Sodium, Potassium, Magnesium, Calcium, Chloride, White-Blood-Count, Hemoglobin, C-reactive-Protein, Creatinine, Carbamide, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), Glucose and pro-brain natriuretic peptide (Pro-BNP).
BEHAVIORAL	Questionnaire	Questionnaire regarding patients quality of life

Timeline

• Start date: 2018-08-15
• Primary completion: 2019-09-03
• Completion: 2022-01-01
• First posted: 2018-08-22
• Last updated: 2019-01-03

Locations

1 site across 1 country: Denmark