Trial Outcomes & Findings for QT Changes as Detected From LINQ ECG During Antiarrhythmic Loading (LINQ QT) (NCT NCT05488470)
NCT ID: NCT05488470
Last Updated: 2025-05-13
Results Overview
The QT intervals during antiarrhythmic loading will be compared for all patients with available LINQ ECG from the baseline anti arrhythmic loading hospitalization to analyze QT changes that may be caused due to antiarrhythmic drugs.
COMPLETED
22 participants
Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported
2025-05-13
Participant Flow
Participant milestones
| Measure |
All Subjects
Anti-arrhythmic loading event
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Subjects
Anti-arrhythmic loading event
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
QT Changes as Detected From LINQ ECG During Antiarrhythmic Loading (LINQ QT)
Baseline characteristics by cohort
| Measure |
Subjects With Completed Baseline Anti Arrhythmic Loading Hospitalization
n=21 Participants
Characteristics of Subjects with completed Baseline Anti Arrhythmic Loading Hospitalization
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
|
Age, Continuous
|
71.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
|
Medical History
Transient Ischemic Attack
|
1 participants
n=99 Participants
|
|
Medical History
Thromboembolism
|
1 participants
n=99 Participants
|
|
Medical History
Stroke
|
2 participants
n=99 Participants
|
|
Medical History
Peripheral Artery Disease
|
2 participants
n=99 Participants
|
|
Medical History
Myocardial Infarction
|
4 participants
n=99 Participants
|
|
Medical History
Hypertension
|
20 participants
n=99 Participants
|
|
Medical History
Diabetes
|
7 participants
n=99 Participants
|
|
Medical History
Coronary Artery Disease
|
8 participants
n=99 Participants
|
|
Medical History
Congestive Heart Failure
|
7 participants
n=99 Participants
|
|
Medical History
Cancer
|
1 participants
n=99 Participants
|
|
Medical History
Aortic Plaque
|
1 participants
n=99 Participants
|
|
Medical History
Atrial Fibrillation
|
21 participants
n=99 Participants
|
|
Medical History
Atrial Flutter
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reportedPopulation: 8 patients (avg. age 68±6.5 years, 63% males) with available LINQ ECG data during the anti arrhythmic loading hospitalization.
The QT intervals during antiarrhythmic loading will be compared for all patients with available LINQ ECG from the baseline anti arrhythmic loading hospitalization to analyze QT changes that may be caused due to antiarrhythmic drugs.
Outcome measures
| Measure |
QTc Interval Trends Observed During the Anti Arrhythmic Loading Hospitalization
n=8 Participants
The maximum QTc interval in the 2-hr period after each of the first four anti arrhythmic doses.
|
|---|---|
|
QT Intervals During Antiarrhythmic Loading Hospitalization
|
21.8 milliseconds
Standard Deviation 9.4
|
Adverse Events
All Subjects
Serious adverse events
| Measure |
All Subjects
n=21 participants at risk
All Subjects Enrolled
|
|---|---|
|
Renal and urinary disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1 • 90 days
|
|
Cardiac disorders
Adverse Drug Reaction
|
4.8%
1/21 • Number of events 1 • 90 days
|
Other adverse events
Adverse event data not reported
Additional Information
Antony Chu, M.D., FACC, FAHA, FHRS, FACP, Director of Complex Ablation - Arrhythmia Services Section
Division of Cardiology at the Rhode Island and Miriam Hospital, Warren Alpert School of Medicine, Brown University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place