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NCT Number: NCT05784051

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

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).

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Key information

About this study

Premature ventricular contractions (PVCs) are frequently encountered in clinical practice, in the setting of underlying heart disease as well as in "normal" hearts. Frequent PVCs have been shown to impact long term prognosis in patients with structurally normal hearts,[1] as well as in documented cardiomyopathy. In both settings, PVCs may cause symptoms and, in rare cases, sudden cardiac death. For about two decades, it has been accepted that frequent PVCs may also induce left ventricular (LV) dysfunction called PVC-induced cardiomyopathy (PVC-iCMP). Indeed, PVC suppression by using drugs or catheter ablation has been associated with full recovery of left ventricular dysfunction.[2-4] De facto, PVC-iCMP diagnosis as well as identification of predictors has always been established retrospectively. Therefore, risk stratification or simply knowing the exact incidence of the disease in exposed patients remain difficult.

European and US guidelines recommend to treat symptomatic PVC patients regardless of the burden or their risk profile, as well as "frequent PVCs" associated with LV dysfunction (Experts tend to consider worthwhile treating for burden >10%, which was the lowest burden associated with PVC-iCMP).

However, there is no clear recommendation for asymptomatic patients exposed to very frequent PVCs, at risk of developing cardiomyopathy. As no previous studies included such population, expert suggested that these patients should be at least closely followed. Consequently, management of such patients is widely heterogeneous.

The hypothesis of this study is that prophylactic suppression of very frequent PVCs (>10%) will prevent or significantly reduce the incidence of PVC-iCMP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

(all must be present):

  • 18 ≤ 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

Exclusion criteria

(any of them):

  • 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

Treatment and study plan

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).

Other names: medical treatment

Control group

Drug

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

Other names: Therapeutic abstention or no modification of therapy

Primary outcomes

  1. occurence of Left ventricular dysfunction (PVC-iCMP)

    Time frame: 24 months

    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).

Secondary outcomes

  1. Rate of Death

    Time frame: 24 months

    Death from any cause

  2. Rate of Cardiovascular Death

    Time frame: 24 months

    measure of safety endpoint: Death cause of death

  3. Rate of Hospitalization for an adverse event

    Time frame: 24 months

    occurence of adverse events (AE) and serious adverse events (SAE) within follow-up that may be linked or not to anti-arrhythmic drugs (AAD) or ablation procedure

  4. Percentage of patients with a PVC burden <10%

    Time frame: during 24 months follow up

    measure of efficacy endpoints:

    PVC burden will be measured the second year following randomization

  5. LVEF variation

    Time frame: 24 months

    LVEF variation(from baseline to M24)

  6. Nt-ProBNP relative variation

    Time frame: 24 months

    Nt-ProBNP relative variation from baseline to M24

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: SUPPRESS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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