|- candidate number||28002|
|- NTR Number||NTR6745|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-okt-2017|
|- Secondary IDs||NL62365.099.17 Regionale Toetsingscommissie Patientgebonden Onderzoek (Leeuwarden)|
|- Public Title||EN: Which drug prevents worsening of paroxysmal atrial fibrillation: verapamil or metoprolol?|
NL: Welk medicijn voorkomt het hardnekkiger worden van paroxismaal atriumfibrilleren: verapamil of metoprolol?
|- Scientific Title||Effects of Verapamil versus metoprolol to prevent progression from Paroxysmal to persistent Atrial Fibrillation|
|- hypothesis||We hypothesize that verapamil reduces progression from paroxysmal to persistent AF, improves rate control, exercise tolerance and quality of life and reduces costs compared to metoprolol.|
|- Healt Condition(s) or Problem(s) studied||Atrial Fibrillation, Metoprolol, Verapamil|
|- Inclusion criteria||In order to be eligible to participate in this trial, a subject must meet all of the following criteria: |
Patients (age > 18) with symptomatic paroxysmal AF with an indication for rate control medication who participate in the RACE 5 registry. Patients must be able and willing to sign informed consent for the randomised study.
|- Exclusion criteria||Exclusion criteria are (history of) persistent AF, previous adverse effects to the study drugs, contra-indication for the study drugs (i.e. heart failure with reduced ejection fraction, symptomatic hypotension, atrioventricular conduction disturbance, severe asthma/COPD), history of pulmonary vein isolation (PVI), pregnancy and breastfeeding. |
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2017|
|- planned closingdate||1-aug-2020|
|- Target number of participants||200|
|- Interventions||Patients are randomized to verapamil slow release 240mg once daily or metoprolol slow release 100mg once daily. Dose adjustments (half or double) can be made upon the response to heart rate or blood pressure. |
|- Primary outcome||Primary outcome variable is incidence of AF progression from paroxysmal to persistent AF or the need for PVI. |
|- Secondary outcome||Main secondary outcome variables are AF burden, heart rate, exercise tolerance, symptom severity, quality of life, and costs.|
|- Timepoints||After inclusion and randomization, baseline assessments including history taking, physical examination, questionnaires (Toronto AF Severity Scale, EQ-5D-5L, sexual function (FSFI or IIEF), iMTA PCQ), transthoracic echocardiography including PA-tdi interval measurement, exercise test during sinus rhythm, and electrocardiogram (ECG) will be performed. Vagal or sympathetic induction of AF will be determined from clinical history. |
Patients will be followed at 1 month, 6 months and 12 months after randomisation, and more often in case of persisting symptoms of AF.
After 1 month, findings from clinical history, physical examination and ECG will determine whether a dose adjustment is required. Dose may be halved or doubled. After 6 and 12 months of follow-up clinical history, physical examination, ECG and questionnaires will be obtained again. During the last follow-up visit, after 12 months of treatment, transthoracic echocardiogram and exercise test will be repeated.
In all patients, remote monitoring recordings will be collected on a daily basis as part of their participation in the RACE 5 registry and evaluated every 3 months in order to assess AF burden and AF progression. Heart rate variability will also be measured to define the presence of vagal or adrenergic AF.
The occurrence of adverse events will be continuously assessed. After 12 months the trial will be finished. Patients will continue care as usual.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. R.G. Tieleman|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R.G. Tieleman|
|- Sponsor/Initiator ||Martini Hospital Groningen|
(Source(s) of Monetary or Material Support)
|Abbott, Medtronic B.V.|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||10-okt-2017 - 22-okt-2017|