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DANTROLEENI KATEKOLIAMIINIHERKÄSSÄ KAMMIOTAKYKARDIASSA

Dantrolene in catecholaminiergic polymorphic ventricular tachycardia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005292-14-FI
Enrollment
6
Registered
2012-12-04
Start date
2013-01-09
Completion date
Unknown
Last updated
2019-02-28

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

Conditions

Catecholaminergic polymorphic ventricular tachycardia MedDRA version: 14.1 Level: LLT Classification code 10036095 Term: Polymorphic ventricular tachycardia System Organ Class: 100000004849

Interventions

Trade Name: Dantrium Product Name: Dantrium Pharmaceutical Form: Powder for infusion CAS Number: 14663-23-1 Other descriptive name: DANT

Sponsors

Heikki Swan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Exercise-provoked premature ventricular complexes RYR2 mutation Age>17 On-going treatment with betablockers 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 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: calcium-channel blocker or metoclopramide medication, inability to do exercise-stress test with bicycle, systolic blood pressure over 160 or diastolic over 95 mmHg, clinically significant angina pectoris or valvular disease, congenital heart disease At resting ECG PQ interval >200 ms, QRS>120 ms, LVH, pre-excitation

Design outcomes

Primary

MeasureTime frame
Main Objective: Assess the antiarrhythmic effects of dantrolene;Secondary Objective: Assess the effects of dantrolene on cardiac repolarization;Primary end point(s): at each minute of exercise: heart rate, number of premature ventricular complexes, number of longest ventricular salvo during exercise stress test after study drug infusion;Timepoint(s) of evaluation of this end point: at each minute of exericse

Secondary

MeasureTime frame
Secondary end point(s): duration of the exercise in minutes sinus rate at the end of each minute achieved maximum sinus rate ;Timepoint(s) of evaluation of this end point: First eight minutes of the recovery phase

Countries

Finland

Contacts

Public ContactHelsinki University Hospital

Heikki Swan

heikki.swan@helsinki.fi+35894711

Outcome results

None listed

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