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SUPPRESS. Prophylactic frequent premature ventricular complexeS sUPPression on left ventriculaR function impairmEnt in aSymptomatic patientS

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516372-14-00
Acronym
APHP180618
Enrollment
298
Registered
2024-09-18
Start date
2025-01-13
Completion date
Unknown
Last updated
2024-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Patients with frequent PVCs and normal LVEF

Brief summary

the development of LV dysfunction (PVC‐iCMP) defined as a 15% relative LVEF decrease (and/or a LVEF <50%) within 2 years following randomization, on cardiac magnetic resonance imaging (cMRI) (or transthoracic echocardiography (TTE) when not possible).

Detailed description

Other efficacy endpoints, Mean PVC burden during the whole follow‐up (M6, M12, M18 and at M24), Percentage of patients with a PVC burden <10% during the second year following randomization (and time to obtain a PVC burden <10%), LVEF variation (from baseline to M24), LV volumes variation (end‐diastolic and systolic volumes) from baseline to M24, Global Longitudinal Strain (GLS) variation from baseline to M24, Cumulative incidence of patients decreasing their GLS >15% from baseline to M24, Nt‐ProBNP relative variation from baseline to M24, Exercise capacity on treadmill (Watts, Mets, MVO2) and NYHA at baseline and M24, Quality of life will be assessed with SF‐36 (Short Form 36) scale administered for both arms at inclusion, at M12 and at M24., Safety endpoints:  Death from any cause  Cardiovascular cause of death  Hospitalization for an adverse event  The nature, frequency, severity and outcome of adverse events (AE) and serious adverse events (SAE) within follow‐up (that may be linked or not to antiarrhythmic drugs (AAD) or ablation procedure)

Interventions

DRUGVERAPAMIL
DRUGNEBIVOLOL
DRUGAMIODARONE
DRUGBISOPROLOL
DRUGDILTIAZEM
DRUGFLECAINIDE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
the development of LV dysfunction (PVC‐iCMP) defined as a 15% relative LVEF decrease (and/or a LVEF <50%) within 2 years following randomization, on cardiac magnetic resonance imaging (cMRI) (or transthoracic echocardiography (TTE) when not possible).

Secondary

MeasureTime frame
Other efficacy endpoints, Mean PVC burden during the whole follow‐up (M6, M12, M18 and at M24), Percentage of patients with a PVC burden <10% during the second year following randomization (and time to obtain a PVC burden <10%), LVEF variation (from baseline to M24), LV volumes variation (end‐diastolic and systolic volumes) from baseline to M24, Global Longitudinal Strain (GLS) variation from baseline to M24, Cumulative incidence of patients decreasing their GLS >15% from baseline to M24, Nt‐ProBNP relative variation from baseline to M24, Exercise capacity on treadmill (Watts, Mets, MVO2) and NYHA at baseline and M24, Quality of life will be assessed with SF‐36 (Short Form 36) scale administered for both arms at inclusion, at M12 and at M24., Safety endpoints:  Death from any cause  Cardiovascular cause of death  Hospitalization for an adverse event  The nature, frequency, severity and outcome of adverse events (AE) and serious adverse events (SAE) within follow‐up (that may be lin

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026