Clinical trial • Not applicable • Cardiology
PROPRANOLOL HYDROCHLORIDE for Andersen-Tawil syndrome|Multifocal ectopic Purkinje-related premature contractions
Not applicable trial of PROPRANOLOL HYDROCHLORIDE for Andersen-Tawil syndrome|Multifocal ectopic Purkinje-related premature contractions.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Andersen-Tawil syndrome|Multifocal ectopic Purkinje-related premature contractions
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-03-2024
- First CTIS Authorization Date
- 10-06-2024
Trial design
Flecainide monotherapy compared with combination therapy of flecainide plus beta-blockers or calcium channel blockers; for MEPPC patients, quinidine compared with flecainide in phase 2. Specific arm doses/schedules not specified in the CTIS record.-controlled Not applicable trial across 1 site in Netherlands.
- Comparator
- Flecainide monotherapy compared with combination therapy of flecainide plus beta-blockers or calcium channel blockers; for MEPPC patients, quinidine compared with flecainide in phase 2. Specific arm doses/schedules not specified in the CTIS record.
- Biomarker Stratified
- True; SCN5A class 4 or 5 variant carrier (MEPPC inclusion criterion)
- Target Sample Size
- 10
Eligibility
Recruits 10 No vulnerable populations selected. Minimum age ≥ 18 years; 'Inability to provide informed consent' is listed as an exclusion..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- No vulnerable populations selected. Minimum age ≥ 18 years; 'Inability to provide informed consent' is listed as an exclusion.
Inclusion criteria
- {"criterion_text":"- One of the following two primary diagnostic criteria A.\tClinical diagnosis of ATS. Genetically confirmed diagnosis (i.e. class 4 or 5 KCNJ2 variant) is not required B.\tClinical diagnosis of MEPPC and carrier of associated class 4 or 5 SCN5A variant"}
- {"criterion_text":"- Has demonstrated a disease phenotype of ATS or MEPPC including ventricular arrhythmia burden at any point during follow-up on Holter monitor or other rhythm monitoring device (i.e. loop recorder, ECG patch)"}
- {"criterion_text":"- Is currently treated with a stable (at least 3 months) dose of flecainide"}
- {"criterion_text":"- Age ≥ 18 years"}
Exclusion criteria
- {"criterion_text":"- Pregnancy"}
- {"criterion_text":"- Inability to take orally administered tablets"}
- {"criterion_text":"- Inability to provide informed consent"}
- {"criterion_text":"- Contra-indication to study medication"}
- {"criterion_text":"- Significant structural heart disease (left ventricular ejection fraction <50%, history or signs of coronary ischemia, suspicion or definitive diagnosis of cardiomyopathy, or moderate/severe valve regurgitation)"}
- {"criterion_text":"- Suspicion or definitive diagnosis of another (heritable) arrhythmia syndrome, e.g. Brugada syndrome, early repolarization syndrome or catecholaminergic polymorphic ventricular tachycardia"}
- {"criterion_text":"- Presence of a short (<350 ms) or prolonged (>480 ms) heart-rate corrected QT interval on the resting ECG at baseline"}
- {"criterion_text":"- History of therapy refractory ventricular arrhythmia or intolerable side-effects on an adequate dose of any study medication, as determined by the treating cardiologist"}
- {"criterion_text":"- Serious known comorbid disease with a life expectancy of less than two years"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Circumstances that prevent follow-up"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The ventricular ectopy burden per 24-hour period.","definition_or_measurement_approach":"Measured as ventricular ectopy burden per 24-hour period using 24-hour electrocardiographic monitoring (Holter or ECG patch); standard 12-lead ECG also performed per protocol."}
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 13
- Consent Approach
- Informed consent must be provided by participants; minimum age is ≥ 18 years. 'Inability to provide informed consent' is an exclusion. No details on assent, age-specific documents, or languages are provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 10
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-05-2024
- Latest Decision Or Authorization Date
- 10-06-2024
- Processing Time Days
- 30
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Amsterdam UMC
- Department Name
- Cardiology
- Principal Investigator Name
- Christian van der Werf
- Principal Investigator Email
- c.vanderwerf@amsterdamumc.nl
- Contact Person Name
- Christian van der Werf
- Contact Person Email
- c.vanderwerf@amsterdamumc.nl
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- PROPRANOLOL
- Active Substance
- PROPRANOLOL HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 160 mg
- Investigational Product Name
- ATENOLOL
- Active Substance
- ATENOLOL, CHLORTALIDONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 100 mg
- Investigational Product Name
- NEBIVOLOL
- Active Substance
- NEBIVOLOL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 10 mg
- Investigational Product Name
- VERAPAMIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 480 mg
- Investigational Product Name
- METOPROLOL
- Active Substance
- METOPROLOL SUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 250 mg
- Investigational Product Name
- BISOPROLOL
- Active Substance
- BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 10 mg
- Investigational Product Name
- FLECAINIDE
- Active Substance
- FLECAINIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 250 mg
- Investigational Product Name
- QUINIDINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 1200 mg
- Combination Treatment
- Yes
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