Effects of Levosimendan in patients being weaned from venoarterial extracorporal membrane oxygenation. A randomized controlled investigator driven phase II trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken, Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

5 Jul 2024 → ongoing

Decision date (initial)

2024-03-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The objective of this trial is to assess the efficacy of Levosimendan in improving indices of cardiac output and pulsatile flow, thus facilitating weaning from ECMO.

Primary outcome:
Change in left ventricular outflow tract velocity time integral measured by Doppler echocardiography from baseline to 72h after initiation ECMO or before cessation of ECMO support, whichever occurs first

Secondary objectives 1

1. • Change in pulse pressure from baseline to 72h after initiation of ECMO or before cessation of ECMO support, whichever occurs first • ECMO weaning failure, defined as death during ECMO support, death within 24 h after ECMO removal or need for reimplantation of ECMO within 24 h. • All cause mortality at 28 days • Urinary output for the first 48 hours post cessation of ECMO support • Central venous saturation at 4, 8, 12, 24 and 48 hours post cessation of ECMO support • Total days requiring ECMO support

Conditions and MedDRA coding

Cardiogenic Shock

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Age ≥ 18 years; • Undergoing ECMO for cardiogenic shock or refractory cardiac arrest

Exclusion criteria 1

1. • Coma with fixed dilatation of pupils that was not induced by drugs or other circumstances indicating likely futility • Mechanical cause of cardiogenic shock (e.g., ventricular septal defect or papillary muscle rupture) • Onset of shock more than 12 hours before screening • Massive pulmonary embolism • Severe peripheral arterial disease precluding insertion of ECMO cannula • Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation) • Age > 90 years • Severe concomitant disease associated with a life expectancy of less than 6 months • Pregnant women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Change in left ventricular outflow tract velocity time integral measured by Doppler echocardiography from baseline to 72h after initiation ECMO or before cessation of ECMO support, whichever occurs first

Secondary endpoints 1

1. Change in pulse pressure from baseline to 72h after initiation of ECMO or before cessation of ECMO support, whichever occurs first; ECMO weaning failure, defined as death during ECMO support, death within 24 h after ECMO removal or need for reimplantation of ECMO within 24 h. All cause mortality at 28 days, Urinary output for the first 48 hours post cessation of ECMO support, Central venous saturation at 4, 8, 12, 24 and 48 hours post cessation of ECMO support, Total days requiring ECMO

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken

Sponsor organisation

Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken

Address

Waehringer Guertel 18-20, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Dr. Robert Zilberszac

Public contact point

Organisation

Medical University Of Vienna

Contact name

Dr. Robert Zilberszac

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine II - Division of Cardiology

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine II - Division of Cardiology

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

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

Application history

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