LEvOsimendaN vs. Placebo Before Tricuspid VAlve Surgery in Patients with Right Ventricular Dysfunction

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]

Decision date (initial)

2024-12-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS - French Ministry of Health

External identifiers

EU CT number

2024-516167-86-00

EudraCT number

2020-005600-19

ClinicalTrials.gov

NCT05233202

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Prophylaxis

To demonstrate the superiority of preoperative levosimendan vs. placebo in preventing post-operative low cardiac output syndrome in patients referred to cardiac surgery for correcting moderate to severe functional tricuspid regurgitation.

Secondary objectives 1

1. to demonstrate the ability of levosimendan in : 1) reducing perioperative mortality and 2) confirm the safety of levosimendan in the setting of tricuspid surgery.

Conditions and MedDRA coding

Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years
2. Written signed informed consent
3. Affiliation to the French health care system (Sécurité Sociale)
4. Patient referred to cardiac surgery for correcting severe to moderate functional tricuspid regurgitation
5. Severe tricuspid regurgitation was defined (one item required) : a. or an effective regurgitant orifice (ERO)>20mm², b. or vena contracta width >7mm, c. or systolic hepatic vein flow blunting or reserval.

Exclusion criteria 16

1. Severe hypotension defined by systolic blood pressure <90mmHg
2. Severe tachycardia (>150/bpm)
3. History of torsade de pointe
4. Organic renal failure defined by creatinine clearance <30mL/min
5. Recent endocarditis (<3 months)
6. Recent myocardial infarction (<3 months)
7. Tricuspid valve perforation or prolapse
8. Cardiogenic shock requiring dobutamine support or cardiac assistance
9. Severe liver injury (CHILD C)
10. Left ventricular obstruction
11. Allergy to levosimedan
12. Current participation in other investigational drug or device studies or being in the exclusion period at the end of a previous study involving human participants, if applicable
13. Pregnant or breastfeeding women
14. Females of childbearing potential without effective method of birth control
15. Patient on AME (state medical aid) unless exemption from affiliation
16. Patient under guardianship (under “tutelle or curatelle or sauvegarde de justice or mandat de protection futur activé ou habilitation familiale” according to French law

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary end point is a composite element reflecting low cardiac output syndrome at 90 days: - 1) Catecholamine infusion persisting beyond 48 hours after cardiac surgery, - 2) Need for circulatory mechanical assist devices in the postoperative period, - 3) Need for renal replacement therapy at any time during intensive care unit stay.

Secondary endpoints 1

1. 1) Mortality at day 90, 2) Each component of the primary end point, 3) The study drug safety was assessed by recording of the incidence refractory hypotension was defined as a failure to increase mean arterial pressure above 60 mmHg despite optimal management.

Investigational products

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

Test 1

Placebo 1

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 Pascal LIM

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Pascal LIM

Locations

1 EU/EEA country · 25 investigational sites

By country

Investigational sites

Results and documents

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

Documents 8 files

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

Application history

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