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.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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.
Background summary
Paroxysmal (self-terminating) atrial fibrillation (AF) has the tendency to
become persistent over time (non-self-terminating). Verapamil and metoprolol
are both registered for rate-control in AF. Animal experimental and human data
suggest that verapamil, but not betablockers, can reduce AF progression.
Previous studies in patients with permanent AF suggest that verapamil exhibits
better rate control, with better exercise tolerance and quality of life,
compared to metoprolol.
Study objective
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.
Study design
A multicentre, prospective, two-arm, open label, randomized controlled trial.
Intervention
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. In total 200
patients with paroxysmal AF will be included. Data will be collected at
baseline, after 1 month, 6 months and 12 months.
Study burden and risks
Both verapamil and metoprolol are registered for rate control in AF and can be
safely administered in the selected study population. Participating patients
visit the hospital four times during one year instead of the usual once yearly
visit. We expect an absolute risk reduction for AF progression of 15% in
patients receiving verapamil versus metoprolol. This will also result in a
lower hospitalization rate and fewer pulmonary vein isolations. Quality of
life, side effects and exercise tolerance will be compared and
cost-effectiveness of the treatments will be calculated.
Van Swietenplein 1
Groningen 9728NT
NL
Van Swietenplein 1
Groningen 9728NT
NL
Listed location countries
Age
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, heart failure with reduced ejection fraction, symptomatic hypotension, atrioventricular conduction disturbance, severe asthma/COPD, history of pulmonary vein isolation (PVI), pregnancy and breastfeeding.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62365.099.17 |
| Other | protocol gaat aangemeld worden bij clinicaltrials.gov |
| OMON | NL-OMON27565 |