Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO

NCT ID: NCT05577195

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2025-12-01

Brief Summary

Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.

Detailed Description

In the past years extensive efforts in developing treatment strategies for patients with cardiogenic shock have been performed. One promising such strategy is active unloading of the left ventricle while simultaneously supporting the circulatory system with veno-arterial extracorporeal membrane oxygenation. Recently, in a multinational, multicenter, retrospective registry, it has been shown that this approach might be associated with lower mortality .

The investigators now seek to extend the evidence on this topic and to test this approach in a prospective, randomized, controlled, multicenter trial. A power calculation has been conducted based on the data from the registry. N=198 patients with cardiogenic shock will be randomized 1:1 to be either treated with an Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation or with veno-arterial extracorporeal membrane oxygenation alone. A blinded interim analysis will be performed, which might lead to an adjustment of the enrollment target. The primary endpoint of this study will be death from any cause 30 days after randomization.

Conditions

Cardiogenic Shock

Keywords

Active left ventricular unloading; VA-ECMO; Impella; Cardiogenic shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Impella + VA-ECMO

Group Type: EXPERIMENTAL

Impella

Intervention Type: DEVICE

To provide active left ventricular unloading in the experimental arm

VA-ECMO

Intervention Type: DEVICE

To provide circulatory support in both arms

VA-ECMO only

Group Type: ACTIVE_COMPARATOR

VA-ECMO

Intervention Type: DEVICE

To provide circulatory support in both arms

Interventions

Impella

To provide active left ventricular unloading in the experimental arm

Intervention Type: DEVICE

VA-ECMO

To provide circulatory support in both arms

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Severe cardiogenic shock due to severe left ventricular dysfunction:

• Systolic blood pressure <90 mmHg or need for catecholamines to maintain such blood pressure
• Signs of impaired organ perfusion with at least one of the following: altered mental status OR cold, clammy skin OR oliguria with urine output <30 ml/h
• Arterial lactate >5 mmol/l

Exclusion Criteria

• Post-cardiotomy cardiogenic shock.
• Cardiogenic shock due to acute rejection in heart transplant recipients.
• Obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism)
• Cardiogenic shock due to other causes (e.g. bleeding, hypothermia)
• Pre-existing Impella treatment.
• Onset of shock >12 hours.
• Mechanical complication of acute myocardial infarction.
• Prolonged resuscitation (>60 minutes).
• Severe peripheral artery disease with infeasibility for Impella or veno-arterial extracorporeal membrane oxygenation implantation.
• Age <18 or >80 years.
• Other severe concomitant disease with life expectancy <6 months.
• Participation in another trial with an intervention or pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Heart and Vascular Center Hamburg

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Dirk Westermann, Prof.

Role: CONTACT

Phone: 0049 40 7410 0

Email: d.westermann@uke.de

Benedikt Schrage, Dr.

Role: CONTACT

Email: b.schrage@uke.de

Facility Contacts

Benedikt Schrage, MD, PhD

Role: primary

References

Schrage B, Sundermeyer J, Blankenberg S, Colson P, Eckner D, Eden M, Eitel I, Frank D, Frey N, Graf T, Kirchhof P, Kupka D, Landmesser U, Linke A, Majunke N, Mangner N, Maniuc O, Mierke J, Mobius-Winkler S, Morrow DA, Mourad M, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Pazzanese V, Radakovic D, Schulze PC, Scherer C, Schwinger RHG, Skurk C, Thiele H, Varshney A, Wechsler L, Westermann D. Timing of Active Left Ventricular Unloading in Patients on Venoarterial Extracorporeal Membrane Oxygenation Therapy. JACC Heart Fail. 2023 Mar;11(3):321-330. doi: 10.1016/j.jchf.2022.11.005. Epub 2023 Jan 11.

Reference Type: DERIVED

PMID: 36724180 (View on PubMed)

Other Identifiers

UNLOAD ECMO

Identifier Type: -

Identifier Source: org_study_id