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Efficacy of Vernakalant in the conversion of atrial fibrillation in critical illness


- candidate number15567
- NTR NumberNTR4213
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-okt-2013
- Secondary IDsNL2013-004442-42 EudraCT
- Public TitleEfficacy of Vernakalant in the conversion of atrial fibrillation in critical illness
- Scientific TitleEfficacy of Vernakalant in the conversion of atrial fibrillation in critical illness
- ACRONYMVINCES
- hypothesisVernakalant is superior to Amiodarone and rate control alone in the acute conversion of recent onset atrial fibrillation (AF) in critically ill patients admitted to the medical ICU.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaInclusion criteria Part A:
Admission to medical ICU
Age > 18 years
Providing informed consent (if necessary by legally acceptable representative)

Additional inclusion criteria Part B:
New onset AF<3 hr
- Exclusion criteriaExclusion criteria Part A (any of the following):
AF on admission
Inability to collect blood samples or 24 hour urine
Major structural cardiac disease as revealed by transthoracic echocardiography (TTE)
Administration of corticosteroids during or prior to admission
Any disease affecting corticosteroid, renine, aldosterone or catecholamine hormone production (eg.: Cushing-, Addisone-, Conn disease, Reninoma, Pheochromocytoma)

Exclusion criteria Part B (any of the following):
AF on admission
Hemodynamically unstable AF (systolic RR<90 mmHg or signs of systemic hypoperfusion)
Atrial Flutter (Afl)
Conversion to sinus rhythm before randomization
Major structural cardiac disease as revealed by TTE
Contraindication against Vernakalant
Contraindication against Amiodarone
Acute coronary syndrome (ACS)
Major, incorrigible electrolyte disturbances
Administration of Amiodarone within 3 months prior to inclusion
Being under active anti-arrhythmic treatment, other than conventional beta-blocker or digoxine
Pregnancy, breast feeding, or being of child-bearing potential and not using adequate contraceptive precautions
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2019
- Target number of participants360
- InterventionsPart A: no interventions are performed. Part A is a prospective observational cohort study meant to investigate the association between stress hormone levels and onset of AF (n=210).
Part B:Administration of Vernakalant, Amiodarone or rate control (1:1:1) (n=150).
- Primary outcomeProportion of critically ill patients admitted to the medical ICU demonstrating conversion to sinus rhythm (SR) from AF within 90 minutes of first exposure to the study drug.
- Secondary outcome Secondary endpoint: Association between stress hormonal markers and onset of AF in critically ill patients admitted to the medical ICU in a maximal period of one week after admission.
Tertiary endpoints:
o Correlation between success rate of pharmacologic conversion and stress hormone levels in critically ill patients admitted to the medical ICU.
o All cause mortality in the three treatment groups.
o All cause mortality comparing rhythm control to rate control
o Duration of hospitalization comparing rhythm control to rate control
o Frequency of acute cerebral or peripheral ischemic events comparing rhythm control to rate control
o Proportion of critically ill patients admitted to the medical ICU maintaining SR after successful initial conversion at 24 hours.

Safety endpoints:
o Nature, frequency, severity and relationship to treatment of adverse events
- TimepointsPrimary endpoint: 90 minutes Secondary endpoint: during admission at the medical ICU
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES Sonja Postma
- CONTACT for SCIENTIFIC QUERIESDr. A. Elvan
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Maatschap Cardiologie Zwolle
- PublicationsN/A
- Brief summaryThe primary goal of the study is to investigate the efficacy and safety of Vernakalant in the acute conversion of AF, as compared to Amiodarone and rate control alone, in critically ill patients admitted to the medical ICU.
- Main changes (audit trail)30-jun-2014: Amendment:
Additional inclusion criteria:
* Part A: "Expected duration of admission > 48h"
* Part B:
- Admission to medical or non-cardiac surgical ICU
- Age > 18 years
- Providing informed consent (if necessary by legally acceptable representative)
- Expected duration of admission > 48h

Exclusion criteria part B:
* Changes in the following two criteria:
- Hemodynamically unstable AF (systolic MAP<60 mmHg or signs of systemic hypoperfusion)
- Pregnancy or breast feeding
* Addition: - Acute decompensated heart failure - AB
- RECORD18-okt-2013 - 20-aug-2015


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