Trial · NCT05631730
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
NCT05631730, Phase 3, Active not recruiting, Oslo University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse. Trials, record NCT05631730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05631730
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
- NCT number
- NCT05631730
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Oslo University Hospital
- Conditions
- Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
- Interventions
- Flecainide, Metoprolol
- First posted
- 2022-11-30
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of ventricular tachyarrhythmias | 12 months | Sum of ventricular fibrillation and ventricular tachycardia (broad complex tachycardia with heart rate \>140/min) on implantable loop recorder during 12 months. Intention-to-treat, superiority. |
| Secondary | Burden of premature ventricular complexes | 12 months | First hierarchical key secondary outcome. Assessed by 24-hour Holter monitoring. Intention-to-treat, superiority |
| Secondary | Change in health-related quality of life | 12 months | Second hierarchical key secondary outcome. Number of patients with ≥5-point increase in Short Form 36 overall summary score. Intention-to-treat, superiority |
| Secondary | Number of severe ventricular tachycardias | 12 months | Third hierarchical key secondary outcome. Sum of (i) non-sustained ventricular tachycardia with syncope, (ii) sustained ventricular tachycardia and (iii) ventricular fibrillation. Intention-to-treat, superiority |
| Secondary | Safety composite | 12 months | Sum of (i) number of adverse events, (ii) number of serious adverse events, and (iii) higher degree atrioventricular (AV)-block (Mobitz type 2 or 3rd-degree AV-block). Safety population. |
| Other | Number of ventricular tachycardias | 12 months | Exploratory outcome of the individual component of the primary endpoint. Ventricular tachycardia (broad complex tachycardia with heart rate \>140/min) on implantable loop recorder during 12 months. |
| Other | Number of ventricular fibrillations | 12 months | Exploratory outcome of the individual component of the primary endpoint. Ventricular fibrillations on implantable loop recorder during 12 months. |
| Other | Burden of premature ventricular complexes | 12 months | Exploratory outcome of the individual component of key secondary endpoints. Assessed by 24-hour Holter monitoring |
| Other | Health-related quality of life | 12 months | Exploratory outcome of the individual component of key secondary endpoints. Number of patients with ≥5-point increase in Short Form 36 overall summary score. |
| Other | Number of severe ventricular arrhythmias | 12 months | Exploratory outcome of the individual component of key secondary endpoints. Sum of (i) non-sustained ventricular tachycardia with syncope, (ii) sustained ventricular tachycardia and (iii) ventricular fibrillation. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05631730
GET https://conductscience.org/api/trials/v1/NCT05631730/registered