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Premature Ventricular ContractionsPhase 4SUPPRESSNCT05784051

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

A Phase 4 study testing Experimental group in people with Premature Ventricular Contractions and Ventricular Dysfunction, Left, run by Assistance Publique - Hôpitaux de Paris.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Experimental group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
No sites listed yet
Study dates
1 Oct 2023to 1 Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • Participation in another research involving the human person
  • Patient under legal protection
  • Non affiliation to a social security scheme

About this study

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).

Read the detailed description

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.

Being tested
Experimental group, Control group
Medical subject headings
Ventricular Premature Complexes, Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental groupDrug

    Also called medical treatment

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

  • Control groupDrug

    Also called Therapeutic abstention or no modification of therapy

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

Study groups in NCT05784051
Study groupRoleWhat they receive
Experimental groupExperimentalPatients 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).
Receives: Drug: Experimental group
Control groupActive comparatorPatients with therapeutic abstention or no treatment modification such as drug therapy/ Therapeutic abstention or no modification of therapy
Receives: Drug: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 24 months

Secondary outcomes (6)

  1. Rate of Death

    Death from any cause

    Measured: 24 months

  2. Rate of Cardiovascular Death

    measure of safety endpoint: Death cause of death

    Measured: 24 months

  3. Rate of Hospitalization for an adverse event

    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

    Measured: 24 months

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

    measure of efficacy endpoints:

    PVC burden will be measured the second year following randomization

    Measured: during 24 months follow up

  5. LVEF variation

    LVEF variation(from baseline to M24)

    Measured: 24 months

  6. Nt-ProBNP relative variation

    Nt-ProBNP relative variation from baseline to M24

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2023
  2. Study start1 Oct 2023 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
298 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05784051
Sponsor's protocol ID
APHP180618
Acronym
SUPPRESS
Status last verified
Sep 2023
First submitted
13 Mar 2023
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Experimental group in people with Premature Ventricular Contractions and Ventricular Dysfunction, Left, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurence of Left ventricular dysfunction (PVC-iCMP) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05784051.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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