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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

13 Jan 2025 → ongoing

Decision date (initial)

2024-09-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

External identifiers

EU CT number

2024-516372-14-00

EudraCT number

2021-002487-46

ClinicalTrials.gov

NCT05784051

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Efficacy

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).

Secondary objectives 3

1. ‐ To evaluate the efficacy, safety, feasibility of prophylactic PVC suppression (drug ± catheter ablation)
2. To prospectively assess the impact of frequent PVCs on clinical, biological and imaging endpoints and understand the chronological development of the PVC‐iCMP to individualize early markers of the disease.
3. To identify in healthy PVCs patients, predictors of subsequent development of PVC‐iCMP to improve risk stratification in this population.

Conditions and MedDRA coding

Asymptomatic Patients with frequent PVCs and normal LVEF

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 18 ≤ Age ≤ 85
2. 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)
3. Asymptomatic status
4. Normal (>or= 55%) LVEF. Patients with underlying cardiomyopathy can be included as long as LV function remains preserved.
5. Signed informed consent

Exclusion criteria 9

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 11

1. Other efficacy endpoints
2. Mean PVC burden during the whole follow‐up (M6, M12, M18 and at M24)
3. Percentage of patients with a PVC burden <10% during the second year following randomization (and time to obtain a PVC burden <10%)
4. LVEF variation (from baseline to M24)
5. LV volumes variation (end‐diastolic and systolic volumes) from baseline to M24
6. Global Longitudinal Strain (GLS) variation from baseline to M24
7. Cumulative incidence of patients decreasing their GLS >15% from baseline to M24
8. Nt‐ProBNP relative variation from baseline to M24
9. Exercise capacity on treadmill (Watts, Mets, MVO2) and NYHA at baseline and M24
10. Quality of life will be assessed with SF‐36 (Short Form 36) scale administered for both arms at inclusion, at M12 and at M24.
11. 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)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Nicolas LELLOUCHE

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Mme Wafa FETHALLAH

Locations

1 EU/EEA country · 31 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications