Effects of acute and chronic oral administration of S 44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1 - A randomized, parallel-group, international multicentre study including a 8-week double-blind placebo controlled period followed by a 8-week single-blind period - Phase II exploratory study
Phase 2
Completed
- Conditions
- catecholaminergic polymorphic ventricular tachycardiainheritated heartrhythmdisorder10007521
- Registration Number
- NL-OMON37671
- Lead Sponsor
- Servier R&D Benelux
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
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;- Presence of an ICD for primary or secondary prevention of ventricular arrhythmia implanted at least 3 months prior to pre-selection
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is:<br /><br>-The mean number of PVCs per minute during the ET (exercise testing) with S<br /><br>44121 versus placebo<br /><br><br /><br>Study parameters for clinical safety measurements: S 44121 versus placebo:<br /><br>-ECG at rest: heart rate, sinus rhythm, PR interval, QRS duration, and QT<br /><br>interval and QRS axis<br /><br>-24-hour Holter recording,<br /><br>-Systolic and diastolic blood pressure,<br /><br>- ICD reading at every visit (ECG events and ICD based therapies)<br /><br>-Adverse events,<br /><br>-Blood clinical laboratory parameters (hematology and biochemistry).</p><br>
- Secondary Outcome Measures
Name Time Method