Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05631730 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse

Study acronym: FLECAPRO
StatusRecruiting
PhasePhase 3
Started2023-01-04
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 30, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-07-29
Study Status v6
Primary completion date2026-02→2026-06
Completion date2026-02→2026-06
2024-07-26
Study Status, Sponsor/Collaborators v5
Re-verified, no change to tracked fields
2024-07-24
Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations, Document Section v4
Eligibility criteria-1 characters
[...] tant use of the following medications (i) CYP2D6 inhibitors/mediatorsinducers, (ii) class I, III or IV antiarrhythmic drugs, (iii) clozap [...]
2024-04-05
Study Status v3
Re-verified, no change to tracked fields
2023-01-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, Document Section v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-12→2026-02
Completion date2027-12→2026-02
Start dateestimated 2022-12→confirmed 2023-01-04
Study sitesdetails revised at 1 of 1 site
2022-12-02
Study Status, Arms and Interventions, Outcome Measures, Eligibility, References v1
Start date2022-11→2022-12
Eligibility criteria+79 characters
[...] r metoprolol use Heart failure (signs or symptoms, elevated NTN-terminal proBNP) according to ICD10 Abnormal liver or kidney function (Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) three times upper normal, estimated glomerular filtration (eGRF) <60) Prior myocardial infarction or ischemic heart disease [...]
Secondary endpointsdetails revised at 1 of 4 entries
2022-11-16
Original filing
FLECAPRO is a randomized controlled crossover trial assessing the effect and safety of adding flecainide to standard beta-blocker therapy to reduce the burden of ventricular arrhythmias in patients with arrhythmic mitral valve prolapse. The primary endpoint of will be assessed using an implantable loop recorder with blinded endpoint adjudication.
Trial Details
NCT Number NCT05631730
Lead Sponsor Oslo University Hospital
Collaborators: The Research Council of Norway, University of Oslo
Conditions Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
Enrollment 50 participants
Start Date 2023-01-04
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-07-30