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The QUEEN-IVF trial: Quinidine versus verapamil in short-coupled idiopathic ventricular fibrillation: An open-label, randomized crossover pilot trial
EU CTIS ID: 2024-511190-30-00
What this study is testing
The objective of this study is to determine the advisability and feasibility of a definitive RCT that will assess quinidine as compared with verapamil in patients with short-coupled IVF in terms of the safety and efficacy with regard to arrhythmic events.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- At least one of the following 3 principal diagnostic criteria for short-coupled IVF: A. Diagnosis of short-coupled IVF, based on any documentation (i.e., ECG, Holter monitor, device electrogram (EGM), or telemetry) of PVT of ≥3 consecutive beats or VF initiated by a PVC with a coupling interval <350 ms B. Isolated PVCs with a coupling interval <350 ms during the index admission after SCA based on a shockable rhythm or (presumed) arrhythmogenic syncope C. DPP6 haplotype carrier
- Functioning transvenous or subcutaneous ICD in place
- Sudden cardiac arrest, (near)syncope, appropriate ICD shock or nonsustained PVT documented by the ICD at least once in the past 2 years
- Genetic testing has been initiated. Results are not required to be known at the time of inclusion. In subjects who are family members of DPP6 carrying index patients, genes other than DPP6 are not required to be tested
- Willing to undergo two assigned treatment periods with verapamil and quinidine
- Age ≥ 18 years
You likely can't join if
- Pregnancy or lactation
- Presence of pause-dependent torsade de pointes [preceding R–R interval prior to the trigger PVC >1500 ms in individuals without pacemaker/ICD or >1300 ms in individuals with pacemaker/ICD] following a stable baseline rhythm. Initiation of ventricular arrhythmia by short-long-short cycles (R–R cycles <1300 ms) with a shortcoupled trigger PVC is allowed
- Significant coronary artery disease (≥50% narrowing of the diameter of the lumen of the left main coronary artery or ≥70% narrowing of the diameter of the lumen of the left anterior descending coronary artery, left circumflex artery or right coronary artery)
- Reversible metabolic or pharmacological/toxicological conditions that may cause electrophysiological findings similar to short-coupled IVF
- Patients who are considered electrically unstable, at physician’s discretion, due to active electrical storm or very frequent nonsustained episodes of short-coupled IVF requiring intravenous or invasive therapy
- Successful radiofrequency ablation of the PVC initiating short-coupled IVF and absence of documented (non)sustained episodes of short-coupled PVT/VF afterwards. The patient will, however, be eligible to participate in the study if ≥ 1 episode of short-coupled PVT/VF is documented after the ablation procedure
See the full eligibility criteria
Who can join
- At least one of the following 3 principal diagnostic criteria for short-coupled IVF: A. Diagnosis of short-coupled IVF, based on any documentation (i.e., ECG, Holter monitor, device electrogram (EGM), or telemetry) of PVT of ≥3 consecutive beats or VF initiated by a PVC with a coupling interval <350 ms B. Isolated PVCs with a coupling interval <350 ms during the index admission after SCA based on a shockable rhythm or (presumed) arrhythmogenic syncope C. DPP6 haplotype carrier
- Functioning transvenous or subcutaneous ICD in place
- Sudden cardiac arrest, (near)syncope, appropriate ICD shock or nonsustained PVT documented by the ICD at least once in the past 2 years
- Genetic testing has been initiated. Results are not required to be known at the time of inclusion. In subjects who are family members of DPP6 carrying index patients, genes other than DPP6 are not required to be tested
- Willing to undergo two assigned treatment periods with verapamil and quinidine
- Age ≥ 18 years
What rules you out
- Pregnancy or lactation
- Presence of pause-dependent torsade de pointes [preceding R–R interval prior to the trigger PVC >1500 ms in individuals without pacemaker/ICD or >1300 ms in individuals with pacemaker/ICD] following a stable baseline rhythm. Initiation of ventricular arrhythmia by short-long-short cycles (R–R cycles <1300 ms) with a shortcoupled trigger PVC is allowed
- Significant coronary artery disease (≥50% narrowing of the diameter of the lumen of the left main coronary artery or ≥70% narrowing of the diameter of the lumen of the left anterior descending coronary artery, left circumflex artery or right coronary artery)
- Reversible metabolic or pharmacological/toxicological conditions that may cause electrophysiological findings similar to short-coupled IVF
- Patients who are considered electrically unstable, at physician’s discretion, due to active electrical storm or very frequent nonsustained episodes of short-coupled IVF requiring intravenous or invasive therapy
- Successful radiofrequency ablation of the PVC initiating short-coupled IVF and absence of documented (non)sustained episodes of short-coupled PVT/VF afterwards. The patient will, however, be eligible to participate in the study if ≥ 1 episode of short-coupled PVT/VF is documented after the ablation procedure
- Intention to perform radiofrequency ablation of the PVC initiating short-coupled IVF during the course of the study
- Serious known comorbid disease with a life expectancy of less than two years
- Ongoing medical condition that is deemed by the principal investigator to interfere with the conduct or assessments of the study or safety of the subjects
- Circumstances that prevent follow-up
- Inability to take orally administered tablets
- Current treatment with class 1 antiarrhythmic medication (other than quinidine), class 3 antiarrhythmic medication, or digoxin, unless this medication is discontinued; patients who are currently treated with amiodarone will not be included due to the long elimination half-life of amiodarone, unless amiodarone was only administered intravenously for a short period of time
- Inability to provide informed consent
- Patients with a history of therapy refractory ventricular arrhythmia on an adequate dose of verapamil or quinidine, as determined by the treating cardiologist.
- Contra-indication to quinidine or verapamil (see section 7.6)
- Significant structural heart disease (left ventricular ejection fraction <50%, suspicion or definitive diagnosis of cardiomyopathy, moderate/severe pulmonary, mitral, or aortic valve stenosis or regurgitation)
- Suspicion or definitive diagnosis of another (heritable) arrhythmia syndrome, e.g. Brugada syndrome, early repolarization syndrome or catecholaminergic polymorphic ventricular tachycardia
- Presence of a short (<350 ms) or prolonged (>480 ms) heart-rate corrected QT interval on the resting ECG at baseline
- Presence of a pathogenic or likely-pathogenic ryanodine receptor 2 (RYR2) mutation
- Presence of ischemia-induced short-coupled ventricular arrhythmia in patient with documented coronary spasm
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.