Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS

NCT05784051 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: APHP180618
• Study Type: interventional
• Target: 298
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of the study is to demonstrate that prophylactic treatment of patients with asymptomatic frequent (\>10%) PVCs is superior to simple follow-up strategy with no therapy to prevent subsequent LV dysfunction at 24 months. The prophylactic treatment is based on drugs ± ablation (ablation can be performed if the PVC burden remain \>10% after 2 lines of AAD treatment since the initiation of the study). The primary endpoint will be 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).

Conditions

Premature Ventricular Contractions; Ventricular Dysfunction, Left

Outcome Measures

Primary Outcomes (1)

• occurence of Left ventricular dysfunction (PVC-iCMP)

  The primary endpoint will be the development of left ventricular 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).

  24 months

Secondary Outcomes (6)

• Rate of Death

  24 months

• Rate of Cardiovascular Death

  24 months

• Rate of Hospitalization for an adverse event

  24 months

• Percentage of patients with a PVC burden <10%

  during 24 months follow up

• LVEF variation

  24 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients treated for PVCs with drug therapy and/or catheter ablation/ medical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain \>10% after 2 lines of AAD treatment).

Drug: Experimental group

Control group

ACTIVE COMPARATOR

Patients with therapeutic abstention or no treatment modification such as drug therapy/ Therapeutic abstention or no modification of therapy

Drug: Control group

Interventions

Experimental group DRUG

medical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain \>10% after 2 lines of AAD treatment).

Also known as: medical treatment

Experimental group

Control group DRUG

patients of this group have no therapeutic or no treatment modification such as drug therapy

Also known as: Therapeutic abstention or no modification of therapy

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ Age ≤ 85
• PVC burden ≥ to 10% regardless of current or preexisting antiarrhythmic drug intake (for instance, a patient under betablocker therapy because of his PVCs or hypertension can be included)
• Asymptomatic status
• Normal (\>or= 55%) LVEF. Patients with underlying cardiomyopathy can be included as long as LV function remains preserved.
• Signed informed consent

You may not qualify if:

• Pregnant woman or Female of childbearing potential without effective method of birth control or nursing woman.
• Patients that can't undergo MRI study
• De novo requirement for antiarrhythmic drug prescription for another indication (e.g. atrial fibrillation…)
• The physician already decided that the patient requires drug initiation or escalation;
• Ischemic cardiomyopathy requiring revascularization (PCI or surgery)
• History of LV dysfunction
• Participation in another research involving the human person
• Patient under legal protection
• Non affiliation to a social security scheme

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Ventricular Premature Complexes; Ventricular Dysfunction, Left

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The SUPPRESS study will be a national multicenter randomized open label trial using the PROBE study design (Prospective Randomized Open Blinded End-point). Patients fulfilling the inclusion criteria (asymptomatic patients with frequent (\> 10%/day) PVCs and normal LVEF) and without any exclusion criteria that agree to enter the protocol will be randomized to: 1. Experimental group: 149 patients treated for PVCs with drug therapy and/or catheter ablation/ medical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain \>10% after 2 lines of AAD treatment). 2. Control group: 149 patients with therapeutic abstention or no treatment modification such as drug therapy/ Therapeutic abstention or no modification of therapy

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share