Genetic characteristics of the Long QT Syndrome that appears with certain pharmacological treatments

Genetic characterization of drug-induced Long QT Syndrome

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000564-28-ES

Enrollment

120

Registered

2018-03-13

Start date

2018-05-23

Completion date

Unknown

Last updated

2018-06-18

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

Conditions

Drug-induced Long QT Syndrome

Interventions

Trade Name: Adrenalina B. Braun Pharmaceutical Form: Solution for injection INN or Proposed INN: EPINEPHRINE HYDROCHLORIDE CAS Number: 55-31-2 Other descriptive name: EPINEPHRINE HYDROCHLORIDE Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients older than 18 years with a confirmed diagnosis of drug-induceded long QT syndrome who want to participate in the study and sign the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Patients under 18 years old -Patients of non-Caucasian ethnicity -Patients with a family history of congenital long QT syndrome -Patients with complete left bundle branch block, stimulated rhythms or non-sinus rhythms not related to SQTL -Patients with electrolyte abnormalities -Patients who do not sign informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: -Identify the genetic alterations associated with drug-induced long QT syndrome in our environment. -To evaluate, in patients with drug-induced long QT syndrome, the response to the adrenaline test and its relationship with the genetic study;Secondary Objective: -Compare the genetic alterations associated with drug-induced long QT syndrome in our environment with those documented in other populations. -To estimate the prevalence of drug-induced long QT syndrome in our environment. -Identify the drugs most commonly associated with drug-induced long QT syndrome in our environment.;Primary end point(s): Regarding the adrenaline test, the main endpoint will be the appearance of a paradoxical response of the QT interval in the electrocardiogram, defined as an extension of this interval> 30 ms with the adrenaline administration.;Timepoint(s) of evaluation of this end point: The timepoint of this endopoint will be evaluated at the time of the adrenaline test, which will perfomed early after inclusion of the patient in the study.	—

Measure

Time frame

Main Objective: -Identify the genetic alterations associated with drug-induced long QT syndrome in our environment. -To evaluate, in patients with drug-induced long QT syndrome, the response to the adrenaline test and its relationship with the genetic study;Secondary Objective: -Compare the genetic alterations associated with drug-induced long QT syndrome in our environment with those documented in other populations. -To estimate the prevalence of drug-induced long QT syndrome in our environment. -Identify the drugs most commonly associated with drug-induced long QT syndrome in our environment.;Primary end point(s): Regarding the adrenaline test, the main endpoint will be the appearance of a paradoxical response of the QT interval in the electrocardiogram, defined as an extension of this interval> 30 ms with the adrenaline administration.;Timepoint(s) of evaluation of this end point: The timepoint of this endopoint will be evaluated at the time of the adrenaline test, which will perfomed early after inclusion of the patient in the study.

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Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Spain

Contacts

Public ContactUICEC Sant Pau

Institut de Recerca H. de la Santa Creu i Sant Pau - IIB Sant Pau

epenag@santpau.cat+34935537636

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026