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RATE PALM: scReening for Atrial fibrillaTion of undiagnosEd Patients in chronic heArt faiLure outpatient clinic through Mydiagnostick


- candidate number16357
- NTR NumberNTR4418
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-feb-2014
- Secondary IDs13NL018 13NL018
- Public TitleRATE PALM: scReening for Atrial fibrillaTion of undiagnosEd Patients in chronic heArt faiLure outpatient clinic through Mydiagnostick
- Scientific TitleRATE PALM: scReening for Atrial fibrillaTion of undiagnosEd Patients in chronic heArt faiLure outpatient clinic through Mydiagnostick
- ACRONYMRATE PALM
- hypothesisThe MDS is able to detect 25% previously undiagnosed Atrial Fibrillation patients in a Chronic heart failure population
- Healt Condition(s) or Problem(s) studiedChronic Heart Failure, Atrial Fibrillation
- Inclusion criteria>18 years Chronic Heart Failure
- Exclusion criteriaAlready diagnosed atrial fibrillation
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate1-jun-2014
- Target number of participants500
- InterventionsMydiagnostick (MDS) is an easy to use, hand-held, heart rate monitoring device. It is not considered as an interventional tool by the CCMO. It is a CE approved instrument, used to screen for Atrial Fibrillation (AF). Patients with no know AF will hold this instrument for 1 minute and the reading will be either 'AF' or 'no AF'. Thsi reading will be followed up by an ECG reading + consultation by cardiologist to confirm diagnosis
- Primary outcomeThe primary outcome is the number of newly diagnosed AF patients confirmed by ECG
- Secondary outcomePercentage of false positives: The number of (positive readings MDS-confirmed readings by ECG)/ all positive readings
- TimepointsAll patients fitting the in and exclusion crietria in a CHF outpatient clinic will be requested to participate in a 3 month time span
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Voorhaar
- CONTACT for SCIENTIFIC QUERIES M. Voorhaar
- Sponsor/Initiator Erasmus Medical Center, Boehringer Ingelheim BV
- Funding
(Source(s) of Monetary or Material Support)
Boehringer Ingelheim
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-feb-2014 - 5-apr-2014


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