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.

Recruitment status

COMPLETED

Target enrollment

22 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 reported

Results posted on

2025-05-13

Participant Flow

Participant milestones

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

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

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 reported

Population: 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

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 events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

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

Phone: 401-444-8689

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place