Effects of acute and chronic oral administration of S44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1
- Conditions
- Catecholaminergic polymorphic ventricular tachycardia type 1MedDRA version: 14.1Level: LLTClassification code 10036095Term: Polymorphic ventricular tachycardiaSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-000579-15-HU
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Male or female patients aged 18 years or more
- Established diagnosis of CPVT type 1
- Treatment with beta-blocker
- Qualifying ETs meeting a predefined degree of severity and stability of the disease
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 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Resting ECG with an abnormality that could preclude a proper interpretation of the ECG obtained during the ETs
- Chronic heart failure
- Structural congenital heart disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method