Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients

Clinical Validation of an iPhone ECG System, QT Substudy

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02241252

Enrollment

Registered

2014-09-16

Start date

2013-09-01

Completion date

2015-05-01

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia, Qt Interval, Variation in

Keywords

ECG, QT interval, Sotalol, Dofetilide, iPhone

Brief summary

This study will validate the recording accuracy of a specific electrical interval of the heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead electrocardiogram (ECG). These measurements will occur in hospitalized patients that are starting either sotalol or dofetilide, since both of these medications can prolong the QT interval.

Detailed description

Patients that were already selected to begin either dofetilide or sotalol in the hospital, will be included in the study. Patients will receive an ECG before and 2 hours after each dose of the medication, which is done to monitor the QT interval. In addition, patients that consent to participate in the study will have an iPhone ECG recording taken in lead positions that correspond to leads I,II, and III. These recordings will be compared and analyzed to assess the accuracy of the QT interval recordings between the two methods.

Interventions

DEVICEiPhone ECG

Please see detailed description for additional information.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* initiation of sotalol or dofetilide * inpatient at University hospital

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
QT interval measurement (in milliseconds)	Participants will be followed for duration of hospital stay during which dofetilide or sotalol are being started, an expected average of 3 days	The QT interval (measured from the start of the QRS to the end of the T wave) will be measured on the 12-lead ECG and on the iPhone rhythm strip recording. Both measurements will be recorded in milliseconds and will be statistically analyzed for bias and agreement.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPaul J Garabelli, MD

University of Oklahoma

PRINCIPAL_INVESTIGATORDwight W Reynolds, MD